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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03290781
Registration number
NCT03290781
Ethics application status
Date submitted
6/09/2017
Date registered
25/09/2017
Date last updated
14/01/2022
Titles & IDs
Public title
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
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Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
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Secondary ID [1]
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2017-000573-37
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Secondary ID [2]
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SHP647-303
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Universal Trial Number (UTN)
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Trial acronym
FIGARO UC 303
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ontamalimab
Other interventions - Placebo
Experimental: Ontamalimab 25 mg - Participants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Experimental: Ontamalimab 75 mg - Participants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Placebo comparator: Placebo - Participants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Treatment: Drugs: Ontamalimab
Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
Other interventions: Placebo
Participants will receive 1 mL of sterile aqueous buffered solution.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Remission Based on Composite Score at Week 52
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Assessment method [1]
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Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
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Timepoint [1]
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At Week 52
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Secondary outcome [1]
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Number of Participants With Endoscopic Remission at Week 52
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Assessment method [1]
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Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration).
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Timepoint [1]
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At Week 52
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Secondary outcome [2]
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Number of Participants With Clinical Remission at Week 52
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Assessment method [2]
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Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
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Timepoint [2]
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At Week 52
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Secondary outcome [3]
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Number of Participants With Sustained Remission at Week 52
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Assessment method [3]
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Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
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Timepoint [3]
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At Week 52
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Secondary outcome [4]
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Number of Participants With Clinical Response Based on Composite Score at Week 52
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Assessment method [4]
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Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding \>=1 point or a sub-score for rectal bleeding \<= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood \& 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease.
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Timepoint [4]
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At Week 52
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Secondary outcome [5]
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Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
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Assessment method [5]
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Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of \<=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease.
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Timepoint [5]
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At Week 52
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Secondary outcome [6]
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Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
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Assessment method [6]
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Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood \& 3=blood alone passes).
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Timepoint [6]
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At Week 52
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Secondary outcome [7]
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Number of Participants With Glucocorticoid-free Remission at Week 52
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Assessment method [7]
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Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease.
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Timepoint [7]
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At Week 52
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Secondary outcome [8]
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Number of Participants With Remission Based on Total Mayo Score at Week 52
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Assessment method [8]
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Remission defined as a total mayo score of less than or equal to (\<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy \[modified, excludes friability\], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease \[spontaneous bleeding, ulceration\].
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Timepoint [8]
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At Week 52
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Secondary outcome [9]
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Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0
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Assessment method [9]
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Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease.
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Timepoint [9]
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At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [10]
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Number of Participants With Sustained Endoscopic Remission at Week 52
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Assessment method [10]
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Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease.
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Timepoint [10]
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At Week 52
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Secondary outcome [11]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [11]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported.
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Timepoint [11]
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From start of study drug administration up to follow-up (Week 64)
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Secondary outcome [12]
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Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab
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Assessment method [12]
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Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported.
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Timepoint [12]
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At Week 12, 24, 36 and 52
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Eligibility
Key inclusion criteria
* Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
* Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
* Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
* Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as:
i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
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Minimum age
16
Years
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Maximum age
81
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
* Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]).
* Participants who are likely to require surgery for UC during the study period.
* Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
* Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
* Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
* Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
* Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
* Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment.
* Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
* Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/04/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2021
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Sample size
Target
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Accrual to date
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Final
366
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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Royal Brisbane & Women's Hospital - Herston
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Mater Hospital Brisbane - South Brisbane
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Royal Adelaide Hospital - Adelaide
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The Alfred Hospital - Box Hill
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St Vincents Hospital Melbourne - PPDS - Melbourne
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Recruitment postcode(s) [1]
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2139 - Concord
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2170 - Liverpool
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4029 - Herston
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4101 - South Brisbane
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5000 - Adelaide
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3065 - Melbourne
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Recruitment outside Australia
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Pleven
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Varna
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Country [51]
0
0
Canada
Query!
State/province [51]
0
0
British Columbia
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Ontario
Query!
Country [53]
0
0
Colombia
Query!
State/province [53]
0
0
Antioquia
Query!
Country [54]
0
0
Colombia
Query!
State/province [54]
0
0
Santander
Query!
Country [55]
0
0
Colombia
Query!
State/province [55]
0
0
Cali
Query!
Country [56]
0
0
Croatia
Query!
State/province [56]
0
0
Grad Zagreb
Query!
Country [57]
0
0
Croatia
Query!
State/province [57]
0
0
Karlovacka Županija
Query!
Country [58]
0
0
Croatia
Query!
State/province [58]
0
0
Bjelovar
Query!
Country [59]
0
0
Croatia
Query!
State/province [59]
0
0
Osijek
Query!
Country [60]
0
0
Croatia
Query!
State/province [60]
0
0
Split
Query!
Country [61]
0
0
Croatia
Query!
State/province [61]
0
0
Virovitica
Query!
Country [62]
0
0
Croatia
Query!
State/province [62]
0
0
Vukovar
Query!
Country [63]
0
0
Croatia
Query!
State/province [63]
0
0
Zadar
Query!
Country [64]
0
0
Czechia
Query!
State/province [64]
0
0
Královéhradecký Kraj
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Olomoucký Kraj
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Praha 4
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Praha 7
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Usti nad Labem
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Ústi Nad Orlici
Query!
Country [70]
0
0
Estonia
Query!
State/province [70]
0
0
Kohta-Järve
Query!
Country [71]
0
0
Estonia
Query!
State/province [71]
0
0
Parnu
Query!
Country [72]
0
0
Estonia
Query!
State/province [72]
0
0
Tallinn
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Baden-Württemberg
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Nordrhein-Westfalen
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Schleswig-Holstein
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Thüringen
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Berlin-Zehlendorf
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Berlin
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Biberach an der Riss
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Frankfurt
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Hamburg
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Munich
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Attiki
Query!
Country [84]
0
0
Greece
Query!
State/province [84]
0
0
Patras
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Thessaloniki
Query!
Country [86]
0
0
Hungary
Query!
State/province [86]
0
0
Budapest
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Békéscsaba
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Debrecen
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Gyula
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Mohacs
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Szekszard
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Szentes
Query!
Country [93]
0
0
Hungary
Query!
State/province [93]
0
0
Székesfehérvár
Query!
Country [94]
0
0
Hungary
Query!
State/province [94]
0
0
Veszprém
Query!
Country [95]
0
0
Hungary
Query!
State/province [95]
0
0
Vác
Query!
Country [96]
0
0
Ireland
Query!
State/province [96]
0
0
Dublin
Query!
Country [97]
0
0
Israel
Query!
State/province [97]
0
0
Jerusalem
Query!
Country [98]
0
0
Israel
Query!
State/province [98]
0
0
Nahariya
Query!
Country [99]
0
0
Israel
Query!
State/province [99]
0
0
Nazareth
Query!
Country [100]
0
0
Israel
Query!
State/province [100]
0
0
Tel Aviv
Query!
Country [101]
0
0
Israel
Query!
State/province [101]
0
0
Tiberias
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Calabria
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Emilia-Romagna
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Lazio
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
Puglia
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Toscana
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Veneto
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Novara
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Pavia
Query!
Country [110]
0
0
Italy
Query!
State/province [110]
0
0
Roma
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
Rozzano (MI)
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Torino
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Hokkaidô
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Hyôgo
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kanagawa
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Saitama
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Tokyo
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Abiko
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Asahikawa
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Chikushino
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Hakodate
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Koganei
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Koga
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Kurume-shi
Query!
Country [125]
0
0
Japan
Query!
State/province [125]
0
0
Matsumoto-shi
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Nagakute
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Nishinomiya
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Oita
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Onomichi
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Osaka-shi
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Osaka
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Otsu-Shi
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Sakai
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Sakura
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Sapporo-shi
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Sapporo
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Sendai
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Shimotsuga-gun
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Takatsuki
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Ôita
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Ôsaka
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Daegu Gwang'yeogsi
Query!
Country [143]
0
0
Korea, Republic of
Query!
State/province [143]
0
0
Gang'weondo
Query!
Country [144]
0
0
Korea, Republic of
Query!
State/province [144]
0
0
Gyeonggido
Query!
Country [145]
0
0
Korea, Republic of
Query!
State/province [145]
0
0
Busan
Query!
Country [146]
0
0
Korea, Republic of
Query!
State/province [146]
0
0
Daegu
Query!
Country [147]
0
0
Korea, Republic of
Query!
State/province [147]
0
0
Incheon
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Seoul
Query!
Country [149]
0
0
Lebanon
Query!
State/province [149]
0
0
Beirut
Query!
Country [150]
0
0
Lebanon
Query!
State/province [150]
0
0
Saida
Query!
Country [151]
0
0
Lithuania
Query!
State/province [151]
0
0
Kaunas
Query!
Country [152]
0
0
Lithuania
Query!
State/province [152]
0
0
Vilnius
Query!
Country [153]
0
0
Mexico
Query!
State/province [153]
0
0
Morelos
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Yucatán
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
Aguascalientes
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Cuautitlán Izcalli
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Distrito Federal
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Durango
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
Monterrey
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Tlalnepantla De Baz
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Zapopan
Query!
Country [162]
0
0
Netherlands
Query!
State/province [162]
0
0
Noord-Brabant
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Noord-Holland
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Zuid-Holland
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Amsterdam
Query!
Country [166]
0
0
New Zealand
Query!
State/province [166]
0
0
Auckland
Query!
Country [167]
0
0
New Zealand
Query!
State/province [167]
0
0
South Island
Query!
Country [168]
0
0
New Zealand
Query!
State/province [168]
0
0
Wellington
Query!
Country [169]
0
0
New Zealand
Query!
State/province [169]
0
0
Hamilton
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Dolnoslaskie
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Kujawsko-pomorskie
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Lódzkie
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Malopolskie
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Mazowieckie
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Podlaskie
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Pomorskie
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Slaskie
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Swietokrzyskie
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Zachodniopomorskie
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Bydgoszcz
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Czestochowa
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Gdynia
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Katowice
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Krakow
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Ksawerow
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Lodz
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Nowa Sól
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Piaseczno
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Poznan
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Rzeszow
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Szczecin
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Tychy
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Warszawa
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Zamosc
Query!
Country [195]
0
0
Portugal
Query!
State/province [195]
0
0
Lisboa
Query!
Country [196]
0
0
Portugal
Query!
State/province [196]
0
0
Braga
Query!
Country [197]
0
0
Portugal
Query!
State/province [197]
0
0
Faro
Query!
Country [198]
0
0
Portugal
Query!
State/province [198]
0
0
Guimarães
Query!
Country [199]
0
0
Portugal
Query!
State/province [199]
0
0
Setubal
Query!
Country [200]
0
0
Romania
Query!
State/province [200]
0
0
Cluj
Query!
Country [201]
0
0
Romania
Query!
State/province [201]
0
0
Bucharest
Query!
Country [202]
0
0
Romania
Query!
State/province [202]
0
0
Bucuresti
Query!
Country [203]
0
0
Romania
Query!
State/province [203]
0
0
Constanta
Query!
Country [204]
0
0
Romania
Query!
State/province [204]
0
0
Iasi
Query!
Country [205]
0
0
Romania
Query!
State/province [205]
0
0
Oradea
Query!
Country [206]
0
0
Romania
Query!
State/province [206]
0
0
Timisoara
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
Kazan
Query!
Country [208]
0
0
Russian Federation
Query!
State/province [208]
0
0
Moscow
Query!
Country [209]
0
0
Russian Federation
Query!
State/province [209]
0
0
Nizhny Novgorod
Query!
Country [210]
0
0
Russian Federation
Query!
State/province [210]
0
0
Novosibirsk
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Rostov-on-Don
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Saint Petersburg
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Samara
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Saratov
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Smolensk
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
St. Petersburg
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Stavropol
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Tyumen
Query!
Country [219]
0
0
Serbia
Query!
State/province [219]
0
0
Belgrade
Query!
Country [220]
0
0
Serbia
Query!
State/province [220]
0
0
Nis
Query!
Country [221]
0
0
Serbia
Query!
State/province [221]
0
0
Vrsac
Query!
Country [222]
0
0
Serbia
Query!
State/province [222]
0
0
Šumadijski Okrug
Query!
Country [223]
0
0
Slovakia
Query!
State/province [223]
0
0
Bratislava
Query!
Country [224]
0
0
Slovakia
Query!
State/province [224]
0
0
Nitra
Query!
Country [225]
0
0
Slovakia
Query!
State/province [225]
0
0
Presov
Query!
Country [226]
0
0
South Africa
Query!
State/province [226]
0
0
Gauteng
Query!
Country [227]
0
0
South Africa
Query!
State/province [227]
0
0
Western Cape
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Córdoba
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Madrid
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
Pontevedra
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Barcelona
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Huelva
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Sevilla
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Kyiv
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Lviv
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Odesa
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Ukraine
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Uzhhorod
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Vinnytsia
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Funding & Sponsors
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
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Trial website
https://clinicaltrials.gov/study/NCT03290781
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No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/81/NCT03290781/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT03290781/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03290781
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