Long-Term Filgotinib for Ulcerative Colitis

(SELECTIONLTE Trial)

Recruiting at 322 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alfasigma S.p.A.

Must be taking: Filgotinib

Disqualifiers: Hypersensitivity, Chronic medical conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 336 weeks

1173 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to observe the safety of filgotinib in adults with ulcerative colitis who were part of an earlier study. Filgotinib reduces inflammation by blocking certain proteins. The goal is to ensure it is safe for extended use.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it mentions that some medications might be prohibited. It's best to discuss your current medications with the study team to see if any changes are needed.

What data supports the effectiveness of the drug Filgotinib for treating ulcerative colitis?

Research shows that Filgotinib, a drug that targets specific proteins involved in inflammation, is effective and safe for treating ulcerative colitis, as demonstrated in real-world studies and clinical trials. ^{1 2 3 4 5}

Is filgotinib safe for humans?

Filgotinib has been shown to be safe for treating ulcerative colitis, with studies supporting its safety in both short-term and long-term use. ^{1 4 5 6 7}

What makes the drug filgotinib unique for treating ulcerative colitis?

Filgotinib is unique because it is an oral medication that selectively inhibits Janus kinase type 1 (JAK1), which helps reduce inflammation in ulcerative colitis. It is effective for both patients who have not used biologic treatments before and those who have, offering a new option for managing moderate to severe cases. ^{1 2 4 6 8}

Research Team

Galapagos Study Director

Principal Investigator

Galapagos NV

Eligibility Criteria

This trial is for adults who've previously been in a filgotinib study for ulcerative colitis. They must agree to use contraception if of childbearing potential, avoid certain vaccines, and have the ability to understand and sign consent forms. Those with known drug hypersensitivity or chronic conditions that could interfere with the study are excluded.

Inclusion Criteria

I am of childbearing age and my pregnancy test was negative.

Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC

Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC

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 subject unsuitable for the study or would prevent compliance with the study protocol

I am not willing to follow the study's birth control requirements.

Known hypersensitivity to the study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive filgotinib or placebo in a blinded manner for up to 336 weeks

336 weeks

Open-label extension

Participants may continue to receive filgotinib in an open-label manner for up to 336 weeks

336 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Filgotinib

Trial Overview The trial is observing long-term safety of filgotinib, an investigational drug for ulcerative colitis. Participants will either continue using filgotinib or receive a placebo based on prior participation in related studies.

Participant Groups

Group I: Filgotinib 200 mg (open-label) Experimental Treatment 1 Intervention

Filgotinib 200 mg for up to 336 weeks

Group II: Filgotinib 200 mg (blinded dosing) Experimental Treatment 2 Interventions

Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Group III: Filgotinib 100 mg (open-label) Experimental Treatment 1 Intervention

Filgotinib 100 mg for up to 336 weeks

Group IV: Filgotinib 100 mg (blinded dosing) Experimental Treatment 2 Interventions

Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks

Group V: Placebo (blinded dosing) Placebo Group 1 Intervention

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Who Is Running the Clinical Trial?

Alfasigma S.p.A.

Lead Sponsor

Trials

28

Recruited

11,500+

Galapagos NV

Lead Sponsor

Trials

140

Recruited

23,500+

Dr. Walid Abi-Saab

Galapagos NV

Chief Medical Officer since 2017

MD from the American University of Beirut, specialization in Internal Medicine and Rheumatology

Dr. Paul Stoffels

Galapagos NV

Chief Executive Officer since 2022

MD from the University of Antwerp, specialization in Infectious Diseases and Tropical Medicine at the Institute of Tropical Medicine in Antwerp

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

References

1. England pubmed.ncbi.nlm.nih.gov

Real-World Cohort Study on the Effectiveness and Safety of Filgotinib Use in Ulcerative Colitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Positioning Filgotinib in the Treatment Algorithm of Moderate to Severe Ulcerative Colitis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Filgotinib for moderately to severely active ulcerative colitis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. [2023]

6. England pubmed.ncbi.nlm.nih.gov

The role of filgotinib in ulcerative colitis and Crohn's disease. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial. [2023]