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)

  • STATUS
    Recruiting
  • sponsor
    Shire
Updated on 25 March 2021

Summary

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)

Description

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX153791
SponsorShire
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must meet all of the following inclusion criteria to be eligible
for enrollment into the study
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
Participants must have achieved clinical response in induction study. Clinical response is defined as
A decrease from the induction study 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 subscore for rectal bleeding greater than or equal to ≥1 point or a subscore for rectal bleeding less than or equal to ≤1 OR
A decrease from the induction study baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore 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
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
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. Males and females of reproductive potential who are sexually active must agree to use acceptable contraception for the duration of the study

Exclusion Criteria

Participants are excluded from the study if any of the following exclusion
criteria are met
Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study
Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study
Participants who are likely to require surgery for UC during the study period
Participants are females who became pregnant during induction study, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods through the conclusion of study participation
Male participants who are planning to donate sperm must agree not to do so 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 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) during study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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