Efavaleukin Alfa for Ulcerative Colitis

Recruiting at 243 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must be taking: 5-aminosalicylates, Corticosteroids, Immunomodulators

Must not be taking: T cell depleting agents, Anti TNF, Anti integrin, IL 12/23, JAK inhibitors

Disqualifiers: Crohn's disease, Toxic megacolon, Extensive surgery, others

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

Compensation: Varies

Number of Visits: Unknown

224 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called efavaleukin alfa to help people with severe ulcerative colitis. The medication aims to reduce inflammation by calming the immune system.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you need to have stable doses of certain medications like 5-aminosalicylates, corticosteroids, and immunomodulators before joining. Some medications, like anti-TNF antibodies and JAK inhibitors, must be stopped a few weeks before the trial.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

Adults aged 18-80 with moderately to severely active ulcerative colitis (UC) diagnosed at least 3 months prior, who haven't responded well or are intolerant to certain UC therapies like corticosteroids, immunomodulators, biologics, or small molecule drugs. They must have a stable dose of current medications and cannot have had recent treatment with T cell depleting agents.

Inclusion Criteria

My ulcerative colitis was diagnosed over 3 months ago, confirmed by tests and a biopsy report.

Participant has provided informed consent prior to initiation of any study specific activities or procedures

I am between 18 and 79 years old.

Exclusion Criteria

I have been diagnosed with a type of inflammatory bowel disease.

I haven't undergone apheresis within the last 2 weeks.

I am currently on, or have recently been on, specific medications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period

12 weeks

Long-term Treatment (optional)

Participants may enter an exploratory long-term treatment period for up to 40 weeks if they may benefit from continued treatment

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

• Efavaleukin alfa

Trial Overview The trial is testing the safety and effectiveness of Efavaleukin Alfa in achieving clinical remission in UC patients compared to a placebo. Participants will receive one of three doses or a placebo for 12 weeks, with an optional extension up to 52 weeks for responders.

Participant Groups

Group I: Arm C: Efavaleukin alfa Experimental Treatment 1 Intervention

Efavaleukin alfa Dose 3 administered by SC injection Q2W

Group II: Arm B: Efavaleukin alfa Experimental Treatment 1 Intervention

Efavaleukin alfa Dose 2 administered by SC injection Q2W

Group III: Arm A: Efavaleukin alfa Experimental Treatment 1 Intervention

Efavaleukin alfa Dose 1 administered by SC injection once every two weeks (Q2W)

Group IV: Arm D: Placebo Placebo Group 1 Intervention

Placebo Q2W

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London