We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    SHP647-303
Previous Study | Return to List | Next Study

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies (FIGARO UC 303)

This study is not yet open for participant recruitment.
Verified October 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT03290781
First Posted: September 22, 2017
Last Update Posted: October 5, 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 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.

Condition Intervention Phase
Ulcerative Colitis Drug: SHP647 Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percentage of Participants in Remission at Week 52 [ Time Frame: Week 52 ]
    Remission is defined as a composite score of patient reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency subscore of 0 or 1 with at least a 1-point change from induction baseline, rectal bleeding subscore of 0 and endoscopic subscore of 0 or 1 (modified, excludes friability).


Secondary Outcome Measures:
  • Percentage of Participants With Endoscopic Remission at Week 52 [ Time Frame: Week 52 ]
    Endoscopic remission is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability).

  • Percentage of Participants With Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is defined by stool frequency subscore of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency subscore, and rectal bleeding subscore of 0,

  • Percentage of Participants With Sustained Remission at Week 52 [ Time Frame: Week 52 ]
    Proportion of subjects with sustained remission, ie, in remission at the SHP647-303 Week 52 visit, among subjects who were in remission at the time of baseline

  • Percentage of Participants With Clinical Response Based on Composite Score at Week 52 [ Time Frame: Week 52 ]
    Clinical response (composite) is defined as a decrease from induction study baseline in the composite score of participant-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.

  • Percentage of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment, at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The Geboes Score will be used to evaluate histologic remission and to complement the endoscopic subscore in the assessment of mucosal healing.

  • Percentage of Participants Achieving Glucocorticoid-free Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit.

  • Percentage of Participants Achieving Glucocorticoid-free Remission at Week 52 [ Time Frame: Week 52 ]
    Glucocorticoid-free remission is defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit.

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration up to Week 68 ]
    Treatment-emergent AEs (TEAEs) are defined as AEs with start dates at the time of or following the first exposure to investigational product.

  • Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event [ Time Frame: From start of study drug administration up to Week 68 ]
    Clinical laboratory assessments include serum chemistry, hematology and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant.

  • Number of Participants With Clinically Significant Findings in Physical Examinations Reported as an Adverse Event [ Time Frame: From start of study drug administration up to Week 68 ]
    Complete physical examinations will be carried out which include review of the following body systems: general appearance, skin, head, eyes, ears, nose, and throat (HEENT), heart, lungs, confrontational visual fields (eyes), breast (optional), abdomen, external genitalia (optional), extremities, neurologic function, back, and lymph nodes. Any changes from the baseline in physical examination findings that are deemed clinically significant in the opinion of the investigator are to be recorded as an AE.

  • Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event [ Time Frame: From start of study drug administration up to Week 68 ]
    Vital sign assessments include blood pressure, pulse, respiratory rate, and temperature. Any deviations from baseline that are deemed clinically significant in the opinion of the investigator are to be recorded as an AE.

  • Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event [ Time Frame: From start of study drug administration up to Week 68 ]
    12-lead ECG will be recorded and a central ECG reader will be used in the study. Any abnormality in ECG assessed by an investigator considered as clinically significant will be reported as AE.

  • Number of Participants who Develop Antidrug Antibodies to SHP647 [ Time Frame: Week 12 up to Week 52 ]
    Serum samples will be analysed for presence of antidrug antibodies to SHP647. Participants who showed positive results for SHP647 will be reported.

  • Percentage of Participants With Remission Based on Total Mayo Score at Week 52 [ Time Frame: Week 52 ]
    Remission is determined by Mayo score of <=2 with no individual subscore exceeding 1, at week 52

  • Percentage of Participants With Clinical Response Based on Total Mayo Score at Week 52 [ Time Frame: Week 52 ]
    Clinical response based on total mayo score is defined as a decrease from induction study baseline in the total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.

  • Percentage of Participants with Remission Based on Partial Mayo Score Over Time [ Time Frame: Baseline up to Week 52 ]
    Partial Mayo score consists of the Mayo score without the endoscopic subscores and ranges from 0 to 9 points. Percentage of participants having partial Mayo score of <=2 with no individual subscore greater than (>) 1 over time will be reported.

  • Percentage of Participants With Clinical Remission Over Time [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants with clinical remission over time with both rectal bleeding and stool frequency subscores of 0 will be reported.

  • Percentage of Participants With Endoscopic Remission at Week 52 With Endoscopic Subscore of 0 [ Time Frame: Week 52 ]
    Percentage of participants with endoscopic remission, as defined by centrally read endoscopic subscore 0 at week 52 will be reported.

  • Percentage of Participants With Deep Remission at the Week 52 [ Time Frame: Week 52 ]
    Percentage of participants in deep remission at week 52 ie, Deep remission is defined as an endoscopic and rectal bleeding subscore of 0, stool frequency <=1 and a Geboes score of <=2.

  • Percentage of Participants With Sustained Endoscopic Remission Based on Centrally Read Endoscopic Subscore [ Time Frame: Week 52 ]
    Percentage of participants with sustained endoscopic remission ie, in endoscopic remission at the Week 52 visit among participants who were in remission at the time of baseline, as defined by a centrally read endoscopic subscore of 0 or 1 (modified, excludes friability) will be evaluated.

  • Percentage of Participants With Sustained Mucosal Healing at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants with sustained mucosal healing at week 52. Mucosal healing is defined by centrally read endoscopic subscore 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2.

  • Percentage of Participants in Sustained Deep Remission at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants in sustained deep remission at week 52 ie, deep remission at week 52 visit among participants who were in remission at the time of baseline will be reported. Deep remission is defined as both endoscopic and rectal bleeding subscores of 0, and stool frequency subscore <=1 and a centrally read Geboes score of <=2.

  • Percentage of Participants in Sustained Clinical Remission Over Time [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants in sustained clinical remission over time ie, clinical remission at baseline and each visit, as defined by stool frequency subscore of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency subscore, and rectal bleeding subscore of 0 will be reported.

  • Percentage of Participants in Sustained Endoscopic Remission at Week 52 [ Time Frame: Week 52 ]
    Percentage of Participants in sustained endoscopic remission at week 52 ie, endoscopic remission at Week 52 visit among participants who were in remission at the time of baseline, with a Mayo endoscopic subscore of 0 will be reported. .

  • Percentage of Participants With Sustained Remission Based on Total Mayo Score [ Time Frame: Week 52 ]
    Percentage of Participants with sustained remission at week 52 ie, remission at Week 52 visit among participants who were in remission at the time of baseline.

  • Percentage of Participants With Sustained Clinical Remission Over Time [ Time Frame: Baseline up to Week 52 ]
    Percentage of participants with sustained clinical remission over time (ie, clinical remission at baseline and each visit) with both rectal bleeding and stool frequency subscores of 0 will be reported.

  • Percentage of Participants Achieving Glucocorticoid-free Clinical Remission Over Time [ Time Frame: Baseline up to Week 52 ]
    Among subjects in Glucocorticoids at study start, the percentage of participants in glucocorticoid-free clinica remission assessed every 4 weeks. Glucocorticoid-free clinical remission is defined as clinical remission in addition to not requiring any treatment with glucocorticoids in subjects who previously received glucocorticoids.

  • Change from Induction Study Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) domains and Total Absolute Scores in Inflammatory Bowel Disease Questionnaire [ Time Frame: Week 12 up Week 52 ]
    IBDQ is a psychometrically validated patient-reported outcome (PRO) instrument for measuring the disease-specific HRQL in participants with inflammatory bowel disease, including UC. The IBDQ consists of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better health-related quality of life (HRQL). A score of at least 170 corresponds to clinical remission and an increase of at least 16 points is considered to indicate a clinically meaningful improvement.

  • Change from Induction Study Baseline in Short Form-36 Health Survey (SF-36), version 2, acute (physical and mental component summary scores and individual domain scores) [ Time Frame: Week 12 up Week 52 ]
    The SF-36 is a generic quality-of-life instrument that has been widely used to assess health-related quality of life (HRQL) of participants. Generic instruments are used in general populations to assess a wide range of domains applicable to a variety of health states, conditions, and diseases. The SF-36 consists of 36 items that are aggregated into 8 multi-item scales (physical functioning, role - physical, bodily pain, general health, vitality, social functioning, role - emotional, and mental health), with scores ranging from 0 to 100. Higher scores indicate better HRQL.

  • Incidence of Hospitalizations and Total Inpatient Days [ Time Frame: Week 68 ]
    Incidence of hospitalizations and total inpatient days during the entire study period were reported.

  • Change From Induction Study Baseline in Abdominal Pain Based on Participant e-Diary [ Time Frame: Week 12 up Week 52 ]
    Change from induction study baseline in abdominal pain based on participant daily e-diary entries will be reported.

  • Change From Induction Study Baseline in Urgency Based on Participant e-Diary [ Time Frame: Week 12 up Week 52 ]
    Change from induction study baseline in urgency item scores based on participant daily e-diary entries will be reported.

  • Change From Induction Study Baseline in Diarrhea Based on Participant e-Diary [ Time Frame: Week 12 up Week 52 ]
    Change from induction study baseline in diarrhea based on participant daily e-diary entries will be reported.

  • Change From Induction Study Baseline in absolute stool frequency Based on Participant e-Diary [ Time Frame: Week 12 up Week 52 ]
    Change from induction study baseline in absolute stool frequency based on participant daily e-diary entries will be reported.

  • Change From Induction Study Baseline in absolute rectal bleeding Based on Participant e-Diary [ Time Frame: Week 12 up Week 52 ]
    Change from induction study baseline in absolute rectal based on participant daily e-diary entries will be reported.

  • Change From Induction Study Baseline in total sign/symptom score based on participant daily e-diary entries (sum of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) will be reported. [ Time Frame: Week 12 up to Week 52 ]
    Change from induction study baseline in total sign/symptom score based on participant daily e-diary entries (sum of rectal bleeding, stool frequency, abdominal pain, diarrhea, and urgency) will be reported.


Estimated Enrollment: 772
Anticipated Study Start Date: February 22, 2018
Estimated Study Completion Date: September 12, 2021
Estimated Primary Completion Date: September 12, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SHP647 25 mg
Participants who received 25 milligram (mg) of SHP647 or placebo and achieved a clinical response in one of the induction studies (SHP647-301 or SHP647-302) will receive 25 mg of SHP647 as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Drug: SHP647
1 milliliter (mL) of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide an intended dose of drug (25 or 75 mg).
Experimental: SHP647 75 mg
Participants who received 75 mg of SHP647 or placebo and achieved a clinical response in one of the induction studies (SHP647-301 or SHP647-302) will receive 75 mg of SHP647 as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Drug: SHP647
1 milliliter (mL) of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide an intended dose of drug (25 or 75 mg).
Placebo Comparator: Placebo
Participants who received 25 mg or 75 mg SHP647 or placebo matched to SHP647 in the induction studies (SHP647-301 or SHP647-302) will receive placebo matched to SHP647 as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Other: Placebo
1 mL of sterile aqueous buffered solution.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 81 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. 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
    2. 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.
  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): NCT03290781


Contacts
Contact: Shire Contact +1 866 842 5335 ClinicalTransparency@shire.com

  Show 81 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03290781     History of Changes
Other Study ID Numbers: SHP647-303
2017-000573-37 ( EudraCT Number )
First Submitted: September 6, 2017
First Posted: September 22, 2017
Last Update Posted: October 5, 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:
Ulcerative colitis

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