A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission (CAPYBARA)

• ClinicalTrials.gov Identifier: NCT05479058
• Recruitment Status: Recruiting
• First Posted: July 29, 2022
• Last Update Posted: March 20, 2023
• Sponsor: Galapagos NV
• Information provided by (Responsible Party): Galapagos NV

Tracking Information

• First Submitted Date: July 26, 2022
• First Posted Date: July 29, 2022
• Last Update Posted Date: March 20, 2023
• Actual Study Start Date: July 26, 2022
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2022)

Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48 [ Time Frame: Week 48 ]

mMCS score is composed of subscores from rectal bleeding, stool frequency, and endoscopic findings (the range of each subscore is 0 to 3 with higher score indicating severe disease). mMCS remission is defined as mMCS score ≤2, with endoscopic subscore of ≤1, stool frequency subscore of ≤1, and a rectal bleeding subscore of 0.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 26, 2022)

• Time to Patient-Reported Outcome Based on 2 Items (PRO2) Flare [ Time Frame: Baseline (Day 1) up to 216 weeks ]
  PRO2 includes items of stool frequency and rectal bleeding. The range of each item score is 0 to 3 with higher score indicating severe disease. PRO2 flare is defined as a PRO2 score worsening of at least 2 points and an absolute PRO2 score of at least 3, with stool frequency subscore ≥2, and rectal bleeding subscore ≥1.
• Time to ES-Confirmed UC Flare [ Time Frame: Baseline (Day 1) up to 216 weeks ]
  An ES-confirmed UC flare is defined as an increase in rectal bleeding subscore by at least 1 point and an increase in stool frequency subscore by at least 2 points and an increase in endoscopic subscore by at least 1 point. The range of each item score is 0 to 3 with higher score indicating severe disease.
• Change From Baseline in C-Reactive Protein (CRP) up to Week 48 [ Time Frame: Baseline, up to Week 48 ]
• Change From Baseline in Fecal Calprotectin (FCP) up to Week 48 [ Time Frame: Baseline, up to Week 48 ]
• Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48 [ Time Frame: Baseline, Week 48 ]
  IBDQ consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation). The total score is the sum of the score from each question and ranges from 32 to 224 with higher scores representing better quality of life.
• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment Discontinuation [ Time Frame: Baseline up to 216 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
• Official Title: A Randomized, Double-blind, Controlled, Multi-center Study to Evaluate the Efficacy and Safety of Dose De-escalation of Orally Administered Filgotinib in Subjects With Ulcerative Colitis in Clinical Remission
• Brief Summary: Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The study is double-blinded to treatment assignment until the last subject has reached the primary analysis time point.

Primary Purpose: Treatment

• Condition: Ulcerative Colitis

Intervention

• Drug: Filgotinib
  Tablets administered orally once daily
  Other Names:

  • GS-6034
  • GLPG0634
• Drug: Placebo
  Tablets administered orally once daily

Study Arms

• Experimental: Filgotinib 200 mg

  Participants will receive filgotinib 200 mg and placebo to match filgotinib 100 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with endoscopic score (ES)-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study.

  Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 200 mg q.d.

  The maximum duration of the treatment will be 216 weeks.

  Interventions:

  • Drug: Filgotinib
  • Drug: Placebo
• Experimental: Filgotinib 100 mg

  Participants will receive filgotinib 100 mg and placebo to match filgotinib 200 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study.

  Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 100 mg q.d.

  The maximum duration of the treatment will be 216 weeks.

  Interventions:

  • Drug: Filgotinib
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 26, 2022): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2026
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Participants must be participating in the SELECTION-LTE study (GS-US-418-3899), currently on 200 mg filgotinib q.d. and fulfill the following conditions:

  • partial Mayo Clinical Score remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to and including screening of the present study;
  • free of corticosteroids for at least 12 weeks prior to and including baseline;
  • FCP ≤250 μg/g at last observation;
  • sigmoidoscopy ES of 0 or 1 (local score) at screening.
• Female participants of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during filgotinib treatment.
• Male participants and female participants of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
• Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of filgotinib in the study.

Key Exclusion Criteria:

• Any chronic medical condition (including but not limited to, cardiac or pulmonary disease, alcohol, or drug abuse) that, in the opinion of the investigator or sponsor, would make the participant unsuitable for the study or would prevent compliance with the study protocol.
• Participant has a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
• Female participant who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and/or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.
• Male participant unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product (IP).
• Participant is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
• Participant has a positive QuantiFERON® tuberculosis (TB) test at screening or participant has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
• History of malignancy except for participants who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
• Participant meets discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Galapagos Medical Information; +3215342900; medicalinfo@glpg.com

• Listed Location Countries: Belgium, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Poland, South Africa, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05479058
• Other Study ID Numbers: GLPG0634-CL-341; 2022-000719-30 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Galapagos NV
• Original Responsible Party: Same as current
• Current Study Sponsor: Galapagos NV
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Galapagos Study Director; Galapagos NV

• PRS Account: Galapagos NV
• Verification Date: March 2023