Summary

for people ages 16-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Brigid Boland

Description

Summary

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD).

Official Title

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Keywords

Crohn's Disease Ulcerative Colitis Immunosuppressants Mesalamine Gastroenteritis Crohn Disease Colitis Ulcer Colitis, Ulcerative 25 mg SHP647 75 mg SHP647

Eligibility

You can join if…

Open to people ages 16-80

  • 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 with Ulcerative Colitis:

  • Participants must have been previously enrolled in study SHP647-301, SHP647-302, or

SHP647-303, and reached 1 of the following clinical trial milestones:

  1. Completed the Week 12 visit in induction study SHP647-301 or SHP647-302, and did not achieve a clinical response. Clinical response is defined as: 1. a decrease from 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 2. a decrease from the induction study (SHP647-301 or SHP647-302) baseline 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.
  2. Completed the Week 52 visit in maintenance study SHP647-303.
  3. Withdrew early from maintenance study SHP647-303 due to treatment failure,defined by an endoscopic subscore that has increased by at least 1 point over baseline in the maintenance study or a value >= 2 plus an increase in clinical subscore (stool frequency + rectal bleeding score) of at least 2 points.Centrally read endoscopic subscores will be used to determine treatment failure.
  4. 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 with Crohn's Disease:

  • Participants must have been previously enrolled in study SHP647-305, SHP647-306, or

SHP647-307, and reached 1 of the following clinical trial milestones:

  1. Completed the Week 16 visit in induction study SHP647-305 or SHP647-306, and did NOT meet the efficacy criteria (clinical and/or endoscopic response/remission as appropriate) for entry into maintenance study SHP647-307.
  2. Completed the Week 52 visit in maintenance study SHP647-307.
  3. Withdrew early from maintenance study SHP647-307 due to treatment failure (or were considered to have failed treatment, at the time of the last visit in study SHP647-307), as defined in the SHP647-307 protocol.
  4. Participants receiving any treatment(s) for CD are eligible provided they have been,and are anticipated to be, on a stable dose for the designated period of time.

You CAN'T join if...

Participants with Ulcerative Colitis:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who permanently discontinued investigational product because of an AE,regardless of relatedness to investigational product, in study SHP647-301, SHP647-302,or SHP647-303.
  • Participants who are likely to require major surgery for UC.
  • Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, 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 through the conclusion of study participation.
  • Male participants who are planning to donate sperm and do not 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 (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 study SHP647-301 or SHP647-302 and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.

Participants with Crohn's Disease:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306, or SHP647-307.
  • Participants who permanently discontinued investigational product because of an AE,regardless of relatedness to investigational product, in study SHP647-305, SHP647-306,or SHP647-307.
  • Participants who are likely to require major surgery for CD.
  • Participants are females who became pregnant during study SHP647-305, SHP647-306, or SHP647-307, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue appropriate contraception methods through the conclusion of study participation.
  • Male participants who are planning to donate sperm and do not 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 (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 study SHP647-305 or SHP647-306 and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-305, SHP647-306, or SHP647-307) or plan to participate in other investigational studies during long-term extension study SHP647-304.

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Kindred Medical Institute for Clinical Trials, LLC not yet accepting patients
    Corona California 92879 United States
  • VA Long Beach Healthcare System not yet accepting patients
    Long Beach California 90822 United States
  • Arizona Digestive Health not yet accepting patients
    Sun City Arizona 85351 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
ID
NCT03283085
Phase
Phase 3
Lead Scientist
Brigid Boland
Study Type
Interventional
Last Updated
March 16, 2018