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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04677179
Registration number
NCT04677179
Ethics application status
Date submitted
8/12/2020
Date registered
21/12/2020
Date last updated
5/09/2023
Titles & IDs
Public title
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
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Scientific title
An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis
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Secondary ID [1]
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J1P-MC-KFAH
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Secondary ID [2]
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17287
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Universal Trial Number (UTN)
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Trial acronym
INSTRUCT-UC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colitis, Ulcerative
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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 - LY3471851
Treatment: Drugs - Placebo
Experimental: High dose LY3471851 - Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Experimental: Low dose LY3471851 - Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Placebo Comparator: Placebo - Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Treatment: Drugs: LY3471851
administered SC
Treatment: Drugs: Placebo
administered SC
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Intervention code [1]
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Treatment: Drugs
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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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Percentage of Participants Who Achieved Clinical Remission at Week 12
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Assessment method [1]
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Clinical remission is defined as achieving a Modified Mayo Score (MMS) sub-score for rectal bleeding=0, stool frequency=0, or stool frequency=1 with = 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Who Achieved Clinical Response at Week 12
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Assessment method [1]
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Clinical response is defined as a decrease in the MMS of =2 points and =30% decrease from baseline, and a decrease of =1 point in the rectal bleeding sub-score from baseline or a rectal bleeding score of 0 or 1. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants Who Achieved Endoscopic Remission at Week 12
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Assessment method [2]
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Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability). The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Percentage of Participants Who Achieved Endoscopic Response at Week 12
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Assessment method [3]
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Endoscopic response is defined as a decrease of =1 point in the MMS endoscopy sub-score from baseline. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Percentage of Participants Who Achieved Symptomatic Remission at Week 12
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Assessment method [4]
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Symptomatic remission is defined as achieving a MMS sub-score for stool frequency=0, or stool frequency=1 with a decrease of =1 point from baseline, and rectal bleeding =0. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percentage of Participants Who Achieved Symptomatic Response at Week 12
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Assessment method [5]
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Symptomatic response is defined as a =30% decrease from baseline in the composite clinical endpoint of the sum of MMS sub-scores of stool frequency and rectal bleeding. The MMS is a scoring system for assessment of UC and is composed of sub-scores of stool frequency (range: 0 to 3, where 0=normal number of stools, 3=5 or more stools more than normal), endoscopy (range: 0 to 3, where 0=normal or inactive disease, 3=severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0=no blood seen, 3=blood alone passed). Total MMS score is sum of all sub-scores and ranges from 0 to 9, with higher scores indicating higher disease activity.
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Timepoint [5]
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Week 12
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Secondary outcome [6]
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Percentage of Participants Who Achieved Histologic Remission at Week 12
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Assessment method [6]
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Histologic Remission is defined as Geboes score <2 or subscores = 0 for Grade 2a, 2b, 3, 4, and 5. The Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7 items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease.
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Timepoint [6]
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Week 12
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Secondary outcome [7]
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Percentage of Participants Who Achieved Histologic-Endoscopic Mucosal Healing (HEMH)
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Assessment method [7]
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HEMH is defined as Geboes score <2 AND endoscopic remission. Geboes score is a 7-item instrument used to identify histologic changes in UC. The 7-items are Grade 0: Architectural changes (0=No abnormality to 3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (0=No increase to 3=Marked increase); Grade 2A: lamina propria eosinophils (0=No increase to 3=Marked increase); Grade 2B: lamina propria neutrophils (0= No increase to 3=Marked increase); Grade 3: Neutrophils in epithelium (0=None to 3=>50% crypts involved); Grade 4: Crypt destruction(0=none to 3=Unequivocal crypt destruction),and Grade 5: Erosion or ulceration:(0=No erosion, ulceration or granulation to 4=Ulcer or granulation tissue). The grade with severe histological observation is considered the Geboes score and ranges from 0 to 4, with higher scores indicating severe disease. Endoscopic remission is defined as achieving a MMS sub-score for endoscopy=0 or 1 (excluding friability).
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
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Assessment method [8]
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IBDQ is a 32-item questionnaire that measures four aspects of participants' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Responses are graded on a 7-point Likert scale, where 7 denotes "not a problem at all" and 1 denotes "a very severe problem." The responses are summed to produce a total score ranging from 32 to 224, with higher score indicating a better quality of life. LS Mean was calculated using ANCOVA (analysis of covariance) model with treatment, baseline value, previous advanced therapy failure status (yes/no), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4 to 6] or [7 to 9]) and region (North America/Europe/Other) as fixed factors.
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Timepoint [8]
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Baseline, Week 12
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Secondary outcome [9]
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Pharmacokinetics (PK): Trough Concentration of LY3471851 (Ctrough) at Week 12
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Assessment method [9]
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C-trough is the concentration of drug in the blood immediately before the next dose was administered.
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Timepoint [9]
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Predose at week 12
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Eligibility
Key inclusion criteria
- Have moderately to severely active ulcerative colitis (UC) as defined by a modified
Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) =2, with endoscopy
performed within 14 days before baseline.
- Have evidence of UC extending proximal to the rectum (with =15 centimeters (cm) of
involved colon).
- Have up-to-date colorectal cancer surveillance performed according to local standard.
- Participants are either one of the following:
- Have failed conventional treatments including inability to tolerate oral or
intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or
methotrexate), or history of corticosteroid dependence (an inability to successfully
taper corticosteroids without return of UC) and neither failed or demonstrated
intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists,
anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
- Have failed advanced therapies such as treatment with 1 or more advance therapies (eg,
tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40
therapies, Janus kinase [JAK] inhibitor) at doses approved for the treatment of UC
with documented history of failure to respond to or tolerate such treatment.
- Have had an established diagnosis of UC of =3 months in duration before baseline which
includes endoscopic evidence of UC and a histopathology report that supports a
diagnosis of UC. Supportive endoscopy and histopathology reports must be available in
the source documents.
- Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated
by a negative serum pregnancy test at the screening visit followed by a negative urine
pregnancy test within 24 hours prior to first exposure to study drug.
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Minimum age
18
Years
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Maximum age
75
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
- Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the
rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
- Have received any of the following for treatment of UC: cyclosporine, tacrolimus,
mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally
administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of
screening.
- Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
- Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg,
tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40
therapies, Janus kinase [JAK] inhibitor).
- Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis
within the small bowel or colon.
- Have any history or evidence of cancer of the gastrointestinal tract
- Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure
within 12 months prior to screening.
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
22/03/2021
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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
9/08/2022
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Sample size
Target
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Accrual to date
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Final
81
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Paratus Clinical Research Brisbane - Albion
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Mater Adult Hospital Brisbane - South Brisbane
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St. Vincent's Hospital - Fitzroy
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2139 - Concord
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4010 - Albion
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4700 - South Brisbane
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment outside Australia
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Timisoara
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Moskva
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Russian Federation
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St. Petersburg
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Country [75]
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0
Slovakia
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State/province [75]
0
0
Banska Bystrica
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Country [76]
0
0
Slovakia
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State/province [76]
0
0
Kosice
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Country [77]
0
0
Ukraine
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State/province [77]
0
0
Kyiv
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Country [78]
0
0
Ukraine
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State/province [78]
0
0
Lvivska Oblast
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Country [79]
0
0
Ukraine
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State/province [79]
0
0
Dnipro
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Country [80]
0
0
Ukraine
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State/province [80]
0
0
Odesa
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Country [81]
0
0
Ukraine
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State/province [81]
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0
Uzhgorod
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Country [82]
0
0
Ukraine
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State/province [82]
0
0
Vinnytsia
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Country [83]
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0
Ukraine
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State/province [83]
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0
Zaporizhzhia
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Country [84]
0
0
United Kingdom
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State/province [84]
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0
Derbyshire
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Country [85]
0
0
United Kingdom
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State/province [85]
0
0
London
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Country [86]
0
0
United Kingdom
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State/province [86]
0
0
Surrey
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Country [87]
0
0
United Kingdom
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State/province [87]
0
0
York
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Nektar Therapeutics
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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0
Eli Lilly and Company
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Address [1]
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0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The reason for this study is to determine if the study drug LY3471851 is safe and effective
in adult participants with active ulcerative colitis (UC). The study treatment will last
about 52 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04677179
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Study Director
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Address
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0
Nektar Therapeutics
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04677179
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