What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to quickly reduce inflammation but are not suitable for long-term use due to side effects. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to block inflammation pathways. Efavaleukin alfa, similar to other biologics, aims to induce clinical remission by modulating immune responses, which is crucial for UC patients to achieve and maintain symptom relief and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include 5-aminosalicylates (5-ASA) like mesalamine, glucocorticoids, and immunomodulators. 5-ASA agents can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, used for short-term therapy, may lead to systemic side effects like adrenal suppression, especially with prolonged use. Immunomodulators, typically reserved for more severe cases, can have side effects including increased risk of infections, liver toxicity, and bone marrow suppression.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Ulcerative Colitis include biologic agents such as infliximab and adalimumab, which are anti-TNF agents used for both induction and maintenance of remission. Other approved biologics include vedolizumab, which targets integrin receptors, and ustekinumab, which targets interleukin-12 and interleukin-23. These treatments, like efavaleukin alfa, aim to modulate the immune response to achieve and maintain clinical remission in patients with moderately to severely active Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Efavaleukin Alfa for the induction of clinical remission in Ulcerative Colitis patients include: 1) Ustekinumab, a monoclonal antibody targeting interleukin-12 and interleukin-23, which has shown efficacy in UC. 2) Vedolizumab, an integrin receptor antagonist that has been effective in both induction and maintenance of remission in UC. 3) Risankizumab, another interleukin-23 inhibitor, which has shown positive results in clinical trials for UC. These therapies represent advanced options for patients seeking new treatments in 2024.

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Cytokine

Efavaleukin Alfa for Ulcerative Colitis

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Demonstrated inadequate response, loss of response, or intolerance to at least 1 conventional therapy, biologic therapy, or targeted small molecule therapy

Moderately to severely active UC as defined by a modified Mayo score of 5 to 9, with a centrally read endoscopy subscore ≥ 2

Must not have

Diagnosis of Crohn's disease, inflammatory bowel disease unclassified, microscopic colitis, ischemic colitis, or clinical findings suggestive of Crohn's disease

Evidence of toxic megacolon, fulminant colitis, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but generally could include immune system reactions, injection site discomfort, gastrointestinal issues, fatigue or allergic responses similar to other treatments affecting the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have tried at least one treatment for my condition without success or could not tolerate it.

Select...

My ulcerative colitis is moderate to severe, with a Mayo score of 5-9 and an endoscopy score of 2 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have severe colon issues, including toxic megacolon or blockages.

Select...

I have had or might need major surgery for ulcerative colitis during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT04987333

88%

Injection site erythema

25%

Nausea

25%

Headache

25%

Injection site pruritus

25%

Swelling

13%

Dizziness

13%

Nasal congestion

13%

Vision blurred

13%

Injection site pain

13%

Pain in extremity

13%

Injection site rash

13%

Rhinitis

13%

Pruritus

13%

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2)

Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1)

Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2)

Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm C: Efavaleukin alfaExperimental Treatment1 Intervention

Efavaleukin alfa Dose 3 administered by SC injection Q2W

Group II: Arm B: Efavaleukin alfaExperimental Treatment1 Intervention

Efavaleukin alfa Dose 2 administered by SC injection Q2W

Group III: Arm A: Efavaleukin alfaExperimental Treatment1 Intervention

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

Group IV: Arm D: PlaceboPlacebo Group1 Intervention

Placebo Q2W

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efavaleukin alfa

2021

Completed Phase 1

~40

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylic acid (5-ASA) agents, corticosteroids, immunomodulators, and biologics. 5-ASA agents, such as mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory mediators. Corticosteroids, like prednisone, suppress the immune response to quickly reduce inflammation but are not suitable for long-term use due to side effects. Immunomodulators, such as azathioprine, alter the immune system to prevent chronic inflammation. Biologics, including anti-TNF agents like infliximab, target specific components of the immune system to block inflammation pathways. Efavaleukin alfa, similar to other biologics, aims to induce clinical remission by modulating immune responses, which is crucial for UC patients to achieve and maintain symptom relief and improve quality of life.