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Trial record 1 of 1 for:    SHP647-304
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A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

This study is not yet open for participant recruitment.
Verified October 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT03283085
First Posted: September 14, 2017
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
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).

Condition Intervention Phase
Ulcerative Colitis Drug: 25 mg SHP647 Drug: 75 mg SHP647 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Long-term Safety and Tolerability of SHP647 in Participants With Moderate to Severe Ulcerative Colitis (UC) [ Time Frame: Baseline to every 4 weeks till follow-up period (16 weeks post last dose) ]
    Safety assessment will be measured by incidence and severity of adverse events (AEs), incidence and nature of serious infections, actual values and change from baseline, as well as the incidence of abnormalities, in laboratory tests, electrocardiogram (ECG), vital signs, and anti-drug antibodies. An AE is 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.


Estimated Enrollment: 1114
Anticipated Study Start Date: January 22, 2018
Estimated Study Completion Date: February 11, 2025
Estimated Primary Completion Date: February 11, 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25 mg SHP647
Participants will be receiving 25 milligram (mg) of SHP647 subcutaneously every 4 weeks until the drug is commercially available, the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study. Allocation will be decided based on how the participant entered into this study.
Drug: 25 mg SHP647
SHP647 sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.
Experimental: 75 mg SHP647
Participants will be receiving 75 mg of SHP647 subcutaneously every 4 weeks until the drug is commercially available, the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study. Allocation will be decided based on how the participant entered into this study.
Drug: 75 mg SHP647
SHP647 sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.

Detailed Description:
Study will enroll Participants from the maintenance study (SHP647-303) and non-responsive participants from induction studies (SHP647-301 and SHP647-302).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 been previously enrolled in study SHP647-301, SHP647-302, or SHP647-303, and reached 1 of the following clinical trial milestones:
  • 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 equals to (≥) 1 point or a subscore for rectal bleeding less than equals 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.
  • Completed the Week 52 visit in maintenance study SHP647-303.
  • 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.
  • 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 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 adverse event (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.
  • Female participants who became pregnant during study SHP647-301, SHP647-302, or SHP647-304, or who are planning to become pregnant during the study period.
  • 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 (for example [e.g.] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [e.g., 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 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 SHP647-301, SHP647-302, or SHP647-303) during long-term extension study SHP647-304.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283085


Contacts
Contact: Shire Contact +1 866 842 533 ClinicalTransparency@shire.com

  Show 80 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03283085     History of Changes
Other Study ID Numbers: SHP647-304
2017-000574-11 ( EudraCT Number )
First Submitted: September 12, 2017
First Posted: September 14, 2017
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shire:
Immunosuppressants
Mesalamine
Ulcerative Colitis
Gastroenteritis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases