ANZCTR - Registration

Registration number

NCT03259308

Ethics application status

Date submitted

21/08/2017

Date registered

23/08/2017

Date last updated

26/04/2021

Titles & IDs

Public title

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

Scientific title

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Secondary ID [1]

2017-000572-28

Secondary ID [2]

SHP647-302

Universal Trial Number (UTN)

Trial acronym

FIGARO UC 302

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ulcerative Colitis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Inflammatory and Immune System

Other inflammatory or immune system disorders

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Ontamalimab
Treatment: Drugs - Placebo

Experimental: Ontamalimab 25 mg - Participants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.

Experimental: Ontamalimab 75 mg - Participants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.

Placebo Comparator: Placebo - Participants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.

Treatment: Drugs: Ontamalimab
Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Treatment: Drugs: Placebo
Participants will receive 1 mL of sterile aqueous buffered solution.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of Participants With Remission Based on Composite Score at Week 12

Timepoint [1]

At Week 12

Secondary outcome [1]

Number of Participants With Endoscopic Remission at Week 12

Timepoint [1]

At Week 12

Secondary outcome [2]

Number of Participants With Clinical Remission at Week 12

Timepoint [2]

At Week 12

Secondary outcome [3]

Number of Participants With Clinical Response Based on Composite Score at Week 12

Timepoint [3]

At Week 12

Secondary outcome [4]

Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12

Timepoint [4]

At Week 12

Secondary outcome [5]

Number of Participants With Remission Based on Total Mayo Score at Week 12

Timepoint [5]

At Week 12

Secondary outcome [6]

Number of Participants With Clinical Response Based on Total Mayo Score at Week 12

Timepoint [6]

At Week 12

Secondary outcome [7]

Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12

Timepoint [7]

At Weeks 4, 8, and 12

Secondary outcome [8]

Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8

Timepoint [8]

At Weeks 4 and 8

Secondary outcome [9]

Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12

Timepoint [9]

At Week 12

Secondary outcome [10]

Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12

Timepoint [10]

At Weeks 4, 8, and 12

Secondary outcome [11]

Number of Participants With Deep Remission at Week 12

Timepoint [11]

At Week 12

Secondary outcome [12]

Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12

Timepoint [12]

Baseline, Week 12

Secondary outcome [13]

Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

Timepoint [13]

Baseline, Week 12

Secondary outcome [14]

Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12

Timepoint [14]

Baseline, Week 12

Secondary outcome [15]

Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12

Timepoint [15]

Baseline, Week 12

Secondary outcome [16]

Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12

Timepoint [16]

Baseline, Week 12

Secondary outcome [17]

Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12

Timepoint [17]

Baseline, Week 12

Secondary outcome [18]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12

Timepoint [18]

Baseline, Weeks 8 and 12

Secondary outcome [19]

Change From Baseline in IBDQ Total Scores at Weeks 8 and 12

Timepoint [19]

Baseline, Weeks 8 and 12

Secondary outcome [20]

Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12

Timepoint [20]

Baseline, Week 12

Secondary outcome [21]

Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12

Timepoint [21]

Baseline, Week 12

Secondary outcome [22]

Number of Participants Based on Inpatient Hospitalization

Timepoint [22]

From start of study up to follow up (Week 29)

Secondary outcome [23]

Median Duration of Total Inpatient Days

Timepoint [23]

From start of study up to follow-up (Week 29)

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 informed
consent and/or assent, as applicable, to participate in the study.

- Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass
index (BMI) >=16.5 kilogram per square metre (kg/m^2).

- Participants must have a documented diagnosis of UC for >=3 months before screening.
The following must be available in each participant's source documentation:

a. A biopsy report to confirm the histological diagnosis. b. A report documenting
disease duration based upon prior colonoscopy. Note: If this documentation is not
available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis
is required during the screening period.

- Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy,
including biopsy sample collection, during screening after all other inclusion
criteria have been met.

- Participants must have moderate to severe active UC, defined as a total Mayo score of
>=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1,
and stool frequency subscore >=1 at baseline.

- Participants must have evidence of UC extending proximal to the rectum (ie, not
limited to proctitis).

- Participants must have had an inadequate response to, or lost response to, or had an
intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate
[ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine
[6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).

- Participants receiving any treatment(s) for UC are eligible provided they have been,
and are anticipated to be, on a stable dose for the designated period of time.

- Participants are males or nonpregnant, nonlactating females who, if sexually active,
agree to comply with the contraceptive requirements of the protocol, or females of
nonchildbearing potential.

Minimum age

16 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

- Participants with indeterminate colitis, microscopic colitis, non-steroidal
anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or
clinical/histologic findings suggestive of Crohn's disease.

- Participants with colonic dysplasia or neoplasia. (Participants with prior history of
adenomatous polyps will be eligible if the polyps have been completely removed.)

- Participants with past medical history or presence of toxic megacolon.

- Participants with colonic stricture, past medical history of colonic resection, a
history of bowel surgery within 6 months before screening, or who are likely to
require surgery for UC during the treatment period.

- Participants at risk for colorectal cancer must have a colonoscopy performed during
the screening period with results available within 10 days before the baseline visit,
unless the participant has had a surveillance colonoscopy performed within 1 year
prior to screening, and any adenomatous polyps found at that examination have been
excised. Colonoscopy report and pathology report (if biopsies are obtained) from the
colonoscopy performed during screening or in the prior year confirming no evidence of
dysplasia and colon cancer must be available in the source documents.

Participants at risk for colorectal cancer include, but are not limited to:

1. Participants with extensive colitis for >=8 years or disease limited to left side of
colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of
age.

2. Participants >=50 years of age at the time of signing of the informed consent form.

- Participants have had prior treatment with ontamalimab (formerly PF-00547659,
SHP647).

- Participants with known or suspected intolerance or hypersensitivity to the
investigational product(s), closely related compounds, or any of the stated
ingredients.

- Participants have received anti-TNF treatment within 60 days before baseline.

- Participants have received any biologic with immunomodulatory properties (other than
anti-TNFs) within 90 days before baseline.

- Participants have received any nonbiologic treatment with immunomodulatory
properties (other than their current background UC treatment) within 30 days before
baseline.

- Participants have ever received anti-integrin/adhesion molecule treatment (example
(eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational
anti-integrin/adhesion molecule).

- Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA,
within 14 days before screening endoscopic procedure.

- Participants have received leukocyte apheresis or selective lymphocyte, monocyte,
or granulocyte apheresis or plasma exchange within 30 days before baseline.

- Participants have participated in other investigational studies within either 30
days or 5 half-lives of investigational product used in the study (whichever is
longer) before baseline.

- Participants have received a live (attenuated) vaccine within 30 days before the
baseline visit.

- Participants with active enteric infections (positive stool culture and
sensitivity), Clostridium difficile infection or pseudomembranous colitis
[Participants with C. difficile infection at screening may be allowed re-test
after treatment], evidence of active cytomegalovirus infection or Listeria
monocytogenes, known active invasive fungal infections such as histoplasmosis or
parasitic infections, clinically significant underlying disease that could
predispose the participants to infections, or a history of serious infection
(requiring parenteral antibiotic and/or hospitalization) within 4 weeks before
the baseline visit.

- Participants with abnormal chest x-ray findings at screening, such as presence of
active tuberculosis (TB), general infections, heart failure, or malignancy.

- Participants with evidence of active or latent infection with Mycobacterium TB or
participants with this history who have not completed a generally accepted full
course of treatment before randomization are excluded. All other participants
must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin
test or interferon gamma release assay (IGRA) performed.

Participants who have no history of previously diagnosed active or latent TB are excluded
if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm]
induration) or a positive IGRA (the latter to be tested at the site's local laboratory)
during screening or within 12 weeks before screening. If IGRA test cannot be performed
locally, a central laboratory may be used, with prior agreement from the sponsor.

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin
(BCG) vaccination, but may be used for any participant. Documentation of IGRA product
used and the test result must be in the participant's source documentation if
performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube
Test.

2. If the results of the IGRA are indeterminate, the test may be repeated, and if a
negative result is obtained, enrollment may proceed. In participants with no history
of treated active or latent TB, a positive test on repeat will exclude the
participant. Participants with a history of active or latent TB infection must follow
instructions for "Participants with a prior diagnosis of active or latent TB are
excluded unless both of the following criteria are met" in this criterion.

3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be
enrolled after consultation with a pulmonary or infectious disease specialist who
determines low risk of infection (ie, participant would be acceptable for
immunosuppressant [eg, anti-TNF] treatment without additional action). This
consultation must be included in source documentation.

Results from a chest x-ray, taken within the 12 weeks before or during screening must show
no abnormalities suggestive of active TB infection as determined by a qualified medical
specialist.

Participants with a prior diagnosis of active or latent TB are excluded unless both of the
following criteria are met:

1. The participant has previously received an adequate course of treatment for either
latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale
where rates of primary multidrug TB resistance are <5%. Participants from regions with
higher rates of primary multidrug TB resistance are excluded) or active (acceptable
multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included
in source documentation. Consultation with a pulmonary or infectious disease
specialist to confirm adequate treatment (ie, participant would be acceptable for
immunosuppressant [eg, anti-TNF] treatment without additional action) must be
performed during the screening period. The consultation report must be included in
source documentation prior to enrollment.

2. A chest x-ray performed within 12 weeks before screening or during screening indicates
no evidence of active or recurrent disease, and documentation of interpretation by a
qualified medical specialist must be included in source documentation.

- Participants with a pre-existing demyelinating disorder such as multiple
sclerosis or new onset seizures, unexplained sensory motor, or cognitive
behavioral, neurological deficits, or significant abnormalities noted during
screening.

- Participants with any unexplained symptoms suggestive of progressive multifocal
leukoencephalopathy (PML) based on the targeted neurological assessment during
the screening period.

- Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum
are allowed.

- Participants with a significant concurrent medical condition at the time of
screening or baseline, including, but not limited to, the following:

1. Any major illness/condition or evidence of an unstable clinical condition (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.

2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
(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).

3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina
pectoris) within 24 weeks before screening.

4. History of significant cerebrovascular disease within 24 weeks before screening.

- Participants who have had significant trauma or major surgery within 4 weeks before
the screening visit, or with any major elective surgery scheduled to occur during the
study.

- Participants with evidence of cirrhosis with or without decompensation.

- Participants with primary sclerosing cholangitis.

- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb).

Note: If a participant tests negative for HBsAg, but positive for HBcAb, the
participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA
is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in
the central laboratory.

- Participants with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb]
and HCVRNA).

Note: Participants who are HCVAb positive without evidence of HCV RNA may be
considered eligible (spontaneous viral clearance or previously treated and cured
[defined as no evidence of HCVRNA at least 12 weeks prior to baseline]).

- Participants with any of the following abnormalities in hematology and/or serum
chemistry profiles during screening.

Note: Screening laboratory tests, if the results are considered by the investigator to
be transient and inconsistent with the participant's clinical condition, may be
repeated once during the screening period for confirmation. Results must be reviewed
for eligibility prior to the screening endoscopy procedure.

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper
limit of normal (ULN).

2. Total bilirubin level >=1.5×ULN or >2.0×ULN if the participant has a known documented
history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3])
or >=1000×10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5×10^9/L (3500 cells/mm^3).

- Absolute neutrophil count (ANC)<2×10^9/L (2000 cells/mm^3).

- Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30
ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study
Equation.

Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be
performed to rule out cirrhosis, unless another etiology has already been identified.

- Participants with known human immunodeficiency virus (HIV) infection based on
documented history, with positive serological test, or positive HIV serologic
test at screening, tested at the site's local laboratory in accordance with
country requirements or tested at the central laboratory.

Note: A documented negative HIV test within 6 months of screening is acceptable and
does not need to be repeated.

- Participants who have, or who have a history of (within 2 years before screening),
serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency
of any kind, including abuse of medical marijuana (cannabis).

- 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.

- Female participants who are planning to become pregnant during the study period.

- 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 are investigational site staff members or relatives of those
site staff members or Participants who are Shire employees directly involved in
the conduct of the study.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Terminated

Date of first participant enrolment

Anticipated

Actual

5/12/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

6/10/2020

Sample size

Target

Accrual to date

Final

279

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Arizona

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

Florida

Country [4]

United States of America

State/province [4]

Georgia

Country [5]

United States of America

State/province [5]

Illinois

Country [6]

United States of America

State/province [6]

Kentucky

Country [7]

United States of America

State/province [7]

Louisiana

Country [8]

United States of America

State/province [8]

Maryland

Country [9]

United States of America

State/province [9]

Massachusetts

Country [10]

United States of America

State/province [10]

Michigan

Country [11]

United States of America

State/province [11]

Missouri

Country [12]

United States of America

State/province [12]

Nevada

Country [13]

United States of America

State/province [13]

New York

Country [14]

United States of America

State/province [14]

North Carolina

Country [15]

United States of America

State/province [15]

Ohio

Country [16]

United States of America

State/province [16]

Oklahoma

Country [17]

United States of America

State/province [17]

Pennsylvania

Country [18]

United States of America

State/province [18]

Texas

Country [19]

United States of America

State/province [19]

Virginia

Country [20]

United States of America

State/province [20]

Wisconsin

Country [21]

Argentina

State/province [21]

Tucumán

Country [22]

Argentina

State/province [22]

Buenos Aires

Country [23]

Argentina

State/province [23]

Córdoba

Country [24]

Belgium

State/province [24]

Oost-Vlaanderen

Country [25]

Belgium

State/province [25]

Vlaams Brabant

Country [26]

Belgium

State/province [26]

West-Vlaanderen

Country [27]

Belgium

State/province [27]

Mouscron

Country [28]

Bosnia and Herzegovina

State/province [28]

Banja Luka

Country [29]

Bulgaria

State/province [29]

Sofia-Grad

Country [30]

Bulgaria

State/province [30]

Pleven

Country [31]

Bulgaria

State/province [31]

Plovdiv

Country [32]

Bulgaria

State/province [32]

Ruse

Country [33]

Bulgaria

State/province [33]

Sevlievo

Country [34]

Bulgaria

State/province [34]

Sofia

Country [35]

Bulgaria

State/province [35]

Varna

Country [36]

Canada

State/province [36]

British Columbia

Country [37]

Canada

State/province [37]

Ontario

Country [38]

Colombia

State/province [38]

Antioquia

Country [39]

Colombia

State/province [39]

Cundinamarca

Country [40]

Colombia

State/province [40]

Santander

Country [41]

Colombia

State/province [41]

Cali

Country [42]

Estonia

State/province [42]

Kohta-Järve

Country [43]

Estonia

State/province [43]

Parnu

Country [44]

Estonia

State/province [44]

Tallinn

Country [45]

Greece

State/province [45]

Attiki

Country [46]

Greece

State/province [46]

Patras

Country [47]

Greece

State/province [47]

Thessaloniki

Country [48]

Hungary

State/province [48]

Bekescsaba

Country [49]

Hungary

State/province [49]

Budapest

Country [50]

Hungary

State/province [50]

Debrecen

Country [51]

Hungary

State/province [51]

Gyula

Country [52]

Hungary

State/province [52]

Mohacs

Country [53]

Hungary

State/province [53]

Szekszard

Country [54]

Hungary

State/province [54]

Szentes

Country [55]

Hungary

State/province [55]

Székesfehérvár

Country [56]

Hungary

State/province [56]

Veszprém

Country [57]

Hungary

State/province [57]

Vác

Country [58]

Ireland

State/province [58]

Dublin

Country [59]

Japan

State/province [59]

Hokkaidô

Country [60]

Japan

State/province [60]

Hyôgo

Country [61]

Japan

State/province [61]

Asahikawa

Country [62]

Japan

State/province [62]

Chikushino

Country [63]

Japan

State/province [63]

Matsumoto-shi

Country [64]

Japan

State/province [64]

Oita

Country [65]

Japan

State/province [65]

Osaka-shi

Country [66]

Japan

State/province [66]

Osaka

Country [67]

Japan

State/province [67]

Sakai

Country [68]

Japan

State/province [68]

Sakura

Country [69]

Japan

State/province [69]

Sendai

Country [70]

Japan

State/province [70]

Shimotsuga-gun

Country [71]

Japan

State/province [71]

Takatsuki

Country [72]

Japan

State/province [72]

Tokyo

Country [73]

Korea, Republic of

State/province [73]

Gang'weondo

Country [74]

Korea, Republic of

State/province [74]

Gyeonggido

Country [75]

Korea, Republic of

State/province [75]

Busan

Country [76]

Korea, Republic of

State/province [76]

Daegu

Country [77]

Korea, Republic of

State/province [77]

Incheon

Country [78]

Korea, Republic of

State/province [78]

Seoul

Country [79]

Lebanon

State/province [79]

Beirut

Country [80]

Lebanon

State/province [80]

Saida

Country [81]

Mexico

State/province [81]

Distrito Federal

Country [82]

Mexico

State/province [82]

Morelos

Country [83]

Mexico

State/province [83]

Yucatán

Country [84]

Mexico

State/province [84]

Aguascalientes

Country [85]

Mexico

State/province [85]

Cuautitlan Izcalli

Country [86]

Mexico

State/province [86]

Durango

Country [87]

Mexico

State/province [87]

Monterrey

Country [88]

Mexico

State/province [88]

Tlalnepantla De Baz

Country [89]

Mexico

State/province [89]

Zapopan, Jalisco

Country [90]

New Zealand

State/province [90]

Auckland

Country [91]

New Zealand

State/province [91]

South Island

Country [92]

New Zealand

State/province [92]

Wellington

Country [93]

New Zealand

State/province [93]

Hamilton

Country [94]

Portugal

State/province [94]

Braga

Country [95]

Portugal

State/province [95]

Guimarães

Country [96]

Portugal

State/province [96]

Lisboa

Country [97]

Portugal

State/province [97]

Portimão

Country [98]

Portugal

State/province [98]

Setubal

Country [99]

Slovakia

State/province [99]

Bratislava

Country [100]

Slovakia

State/province [100]

Nitra

Country [101]

Slovakia

State/province [101]

Presov

Country [102]

Spain

State/province [102]

Córdoba

Country [103]

Spain

State/province [103]

Madrid

Country [104]

Spain

State/province [104]

Pontevedra

Country [105]

Spain

State/province [105]

Barcelona

Country [106]

Spain

State/province [106]

Huelva

Country [107]

Spain

State/province [107]

Sevilla

Country [108]

Spain

State/province [108]

Valencia

Country [109]

Switzerland

State/province [109]

Zürich (de)

Country [110]

Turkey

State/province [110]

Istanbul

Country [111]

Turkey

State/province [111]

Mersin

Country [112]

Ukraine

State/province [112]

Chernivets'ka Oblast

Country [113]

Ukraine

State/province [113]

Kharkivs'ka Oblast

Country [114]

Ukraine

State/province [114]

Vinnyts'ka Oblast

Country [115]

Ukraine

State/province [115]

Dnipro

Country [116]

Ukraine

State/province [116]

Kharkiv

Country [117]

Ukraine

State/province [117]

Kherson

Country [118]

Ukraine

State/province [118]

Kryvyi Rih

Country [119]

Ukraine

State/province [119]

Kyiv

Country [120]

Ukraine

State/province [120]

Lviv

Country [121]

Ukraine

State/province [121]

Odesa

Country [122]

Ukraine

State/province [122]

Uzhhorod

Country [123]

Ukraine

State/province [123]

Vinnytsia

Country [124]

Ukraine

State/province [124]

Zaporizhzhia

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Shire

Country

Ethics approval

Ethics application status

Summary

Brief summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based
on composite score of patient-reported symptoms and centrally read endoscopy, in participants
with moderate to severe ulcerative colitis (UC).

Trial website

https://clinicaltrials.gov/ct2/show/NCT03259308

Public notes

Contacts

Principal investigator

Name

Study Director

Address

Shire

Country

Phone

Email

Contact person for public queries

Name

Address

Country

Phone

Email

Contact person for scientific queries

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03259308