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Cytokine

Efavaleukin Alfa for Ulcerative Colitis

Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 weeks
Awards & highlights

Study Summary

This trial is looking at whether or not a new drug, efavaleukin alfa, can help people with UC achieve clinical remission. Participants will be randomly assigned to receive either the drug or a placebo, and the effects will be monitored over the course of 12 weeks. There is also the option to enter an exploratory long-term treatment period for up to 52 weeks total.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Clinical Remission at Week 12
Secondary outcome measures
Therapeutic procedure
Number of Participants with Clinical Response at Week 12
Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
+3 more

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT04987333
75%
Injection site erythema
38%
Headache
38%
Rash
38%
Urticaria
25%
Injection site rash
25%
Injection site pruritus
13%
Oropharyngeal pain
13%
Fatigue
13%
Myalgia
13%
Hepatocellular injury
13%
Palpitations
13%
Pain
13%
Injection site discolouration
13%
Nasopharyngitis
13%
Arthropod bite
13%
Injection site pain
13%
Urticaria papular
13%
Pyrexia
13%
Hyperaemia
13%
Muscle twitching
13%
Sars-cov-2 test positive
13%
Pruritus
13%
Pain in extremity
13%
Nasal congestion
13%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
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)
Group 4: Caucasian 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

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,371 Previous Clinical Trials
1,377,786 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
1,784 Patients Enrolled for Ulcerative Colitis
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,259 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
784 Patients Enrolled for Ulcerative Colitis

Media Library

Efavaleukin alfa (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04987307 — Phase 2
Ulcerative Colitis Research Study Groups: Arm B: Efavaleukin alfa, Arm C: Efavaleukin alfa, Arm A: Efavaleukin alfa, Arm D: Placebo
Ulcerative Colitis Clinical Trial 2023: Efavaleukin alfa Highlights & Side Effects. Trial Name: NCT04987307 — Phase 2
Efavaleukin alfa (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987307 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the history of research surrounding Efavaleukin alfa?

"Efavaleukin alfa was first studied in 2021 at the University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD. A total of 18,291 trials have been completed to date, with 2 ongoing studies. The majority of these clinical trials take place in Kissimmee, Florida."

Answered by AI

Would this treatment be appropriate for patients who are over the age of 40?

"The target population for this clinical trial are individuals who are 80 years old or younger and have already celebrated their 18th birthday."

Answered by AI

Could you give me the total amount of people who have signed up for this research project?

"That is accurate. The most recent update on clinicaltrials.gov shows that this research project is still looking for volunteers. Originally posted on 1/31/2022, the study requires 320 participants and so far 30 locations have been approved."

Answered by AI

Can you please tell me how many places this research is being conducted?

"In addition to IHS Health Research in Kissimmee, Florida, Clinical Research Institute of Michigan (CRIM) in Troy, Michigan, and ANRC Research in El Paso, Texas; this clinical trial is also taking place at 30 other locations."

Answered by AI

Is this a groundbreaking clinical trial?

"Efavaleukin alfa has been under scientific scrutiny since early last year. After the first official trial in 2021, which was funded by Amgen and had 320 participants, Efavaleukin alfa received Phase 2 drug approval. As of now, there are two ongoing studies involving Efavaleukin alfa with test subjects in 28 countries and 126 cities."

Answered by AI

Are there any slots still available for participants in this trial?

"The clinicaltrials.gov website provides evidence that this study is still recruiting patients; the listing was first posted on January 31st, 2022 and updated as recently as November 2nd, 2022."

Answered by AI

What have been the findings regarding Efavaleukin alfa's safety profile?

"Efavaleukin alfa's score of 2 indicates that, while there is no data currently supporting its efficacy, Phase 2 trials have shown that it is a safe medication."

Answered by AI

If I am willing, can I take part in this research?

"Candidates for this ulcer clinical trial must be between 18 and 80 years old. Around 320 total people are needed for the study."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Atlanta Gastroenterology Associates
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
2022. "Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987307.
All > Ulcerative Colitis > Colitis
~109 spots leftby Jul 2025
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