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

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ClinicalTrials.gov Identifier: NCT03283085
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief 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).

Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Drug: 25 mg SHP647 Drug: 75 mg SHP647 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : June 3, 2025
Estimated Study Completion Date : June 3, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity [ Time Frame: Baseline up to 16 weeks post end of treatment (EOT) [up to 7 years] ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) are defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product. The TEAEs will be further categorized based on severity as mild (may require only minimal treatment) to severe (may require intensive therapeutic intervention).

  2. Number of Participants With Serious Infections [ Time Frame: Baseline up to 16 weeks post EOT (up to 7 years) ]
    Number of participants with serious infections will be assessed.

  3. Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event [ Time Frame: Baseline up to 16 weeks post EOT (up to 7 years) ]
    Clinical laboratory assessments include hematology, serum chemistry and urinalysis. Any clinically significant change in the clinical laboratory value from baseline will be recorded as an AE.

  4. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event [ Time Frame: Baseline up to EOT (up to 7 years) ]
    12-lead ECG will be recorded. Any clinically significant change in ECG will be recorded as an AE.

  5. Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event [ Time Frame: Baseline up to 16 weeks post EOT (up to 7 years) ]
    Vital sign assessments include blood pressure, pulse, respiratory rate and temperature. Any clinically significant change in vital signs from baseline will be recorded as an AE.

  6. Number of Participants who Developed Antidrug Antibodies to SHP647 [ Time Frame: Baseline up to EOT (up to 7 years) ]
    Number of participants with presence of antidrug antibodies to SHP647 will be assessed.



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
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 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.
  • 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.
  • 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.

Exclusion Criteria:

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.

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 5335 ClinicalTransparency@shire.com

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Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03283085     History of Changes
Other Study ID Numbers: SHP647-304
2017-000574-11 ( EudraCT Number )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
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
Crohn's disease
Gastroenteritis

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