Long-Term Filgotinib for Ulcerative Colitis

(SELECTIONLTE Trial)

Not currently recruiting at 403 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the long-term safety of filgotinib, a potential treatment for ulcerative colitis (UC), which causes inflammation and sores in the colon. Participants will receive either a high or low dose of filgotinib or a placebo to monitor their responses over time. Individuals who previously participated in a UC study with filgotinib and completed all necessary steps might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment for UC.

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.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that filgotinib is generally well-tolerated by people with ulcerative colitis. In earlier studies, the 200 mg dose of filgotinib demonstrated a strong long-term safety record. Serious side effects led only about 2 out of every 91 people to stop taking the drug, while moderate side effects occurred in about 9 out of every 91 people. This suggests that the treatment is mostly safe.

For the 100 mg dose, studies suggest it poses a low risk. Filgotinib appears safe for individuals with both ulcerative colitis and rheumatoid arthritis. Overall, filgotinib has a low rate of serious side effects, making it a promising choice for those seeking treatment options. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Most treatments for ulcerative colitis, like aminosalicylates, corticosteroids, and immunosuppressants, focus on reducing inflammation and suppressing the immune system. But Filgotinib works differently by targeting and inhibiting Janus kinase 1 (JAK1), an enzyme involved in the inflammatory process. Researchers are excited about Filgotinib because it offers a more targeted approach, potentially reducing inflammation with fewer side effects than broader immune suppressants. Additionally, Filgotinib's oral administration makes it a convenient option compared to some current treatments that require injections.

What evidence suggests that filgotinib might be an effective treatment for ulcerative colitis?

Studies have shown that filgotinib effectively treats ulcerative colitis (UC). In this trial, participants will receive either a 200 mg or 100 mg dose of filgotinib, or a placebo. Specifically, 37.2% of patients taking the 200 mg dose were symptom-free at Week 58, compared to only 11.2% of those on a placebo. Long-term use also yielded better results for this dosage. For the 100 mg dose, 23.8% of patients were symptom-free at Week 58, outperforming the placebo group. In real-world settings, 65% of patients showed improvement, and 51% were symptom-free. Overall, filgotinib is considered a promising treatment for UC. ^{2 4 5 6 7}

Who Is on the Research Team?

Galapagos Study Director

Principal Investigator

Galapagos NV

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11798541/

Real-world assessment of effectiveness and safety ... At the post-induction review, clinical response and remission were achieved in 65% and 51% of patients, respectively. There was a reduction in ...

2. academic.oup.com academic.oup.com/ecco-jcc/article/19/1/jjad187/7464040

Real-world Cohort Study on the Effectiveness and Safety of ... Our findings demonstrate that filgotinib is an effective and low-risk treatment option for these patients. Ulcerative colitis, small molecule, ...

3. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(24)00272-3/fulltext

a phase 3, double-blind, randomised, placebo-controlled trial Results from DIVERSITY support the safety assessments of filgotinib reported in patients with ulcerative colitis and rheumatoid arthritis.

4. gilead.com gilead.com/news/news-details/2020/phase-2b3-trial-shows-efficacy-of-filgotinib-for-the-induction-and-maintenance-of-remission-in-moderately-and-severely-active-ulcerative-colitis

Phase 2b/3 Trial Shows Efficacy of Filgotinib for the ... “These study results showed that filgotinib reduced bleeding and stool frequency while also achieving remission across a range of measures, ...

5. irjournal.org irjournal.org/journal/view.php?doi=10.5217/ir.2024.00007

post hoc analysis of the phase 2b/3 SELECTION study Among patients receiving filgotinib 100 mg, 23.8% achieved clinical remission at week 58 (vs. 13.5% with placebo, P=0.0420); clinical remission ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39086130/

Long-term safety and efficacy of filgotinib for the treatment ... Safety results showed a proven long-term benefit-risk profile. FIL200-treated CDC achievers had better long-term outcomes than non-achievers.

7. rheumatologyadvisor.com rheumatologyadvisor.com/news/low-cardiovascular-malignancy-risks-with-filgotinib-in-ra-uc/

Filgotinib Safety Data Shows Low Cardiovascular and ... Adverse event incident rates were low overall across both diagnosis groups. These data support the recommendation of filgotinib dose adjustment ...