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Interleukin-2 (IL-2) Agonist
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline of study 20170104 to week 104 of long term extension study (up to approximately 156 weeks)
Awards & highlights
Study Summary
This trial will study the long-term safety of a drug for people with moderate to severe ulcerative colitis.
Who is the study for?
This trial is for people with moderate to severe ulcerative colitis who finished a previous phase 2 study and might benefit from more treatment. They must be able to follow the study plan and not have any other health issues that could interfere or pose a risk. Pregnant women, those planning pregnancy, or breastfeeding are excluded, as well as anyone with certain infections or cancer diagnosed in the earlier study.Check my eligibility
What is being tested?
The trial tests the long-term safety of Efavaleukin Alfa in treating ulcerative colitis compared to a placebo. Participants previously involved in an initial dose-finding study will continue treatment to see how well they tolerate it over time and if it remains effective.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will monitor for any adverse reactions due to Efavaleukin Alfa use over an extended period. This includes watching out for new symptoms or changes in their condition related to the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline of study 20170104 to week 104 of long term extension study (up to approximately 156 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline of study 20170104 to week 104 of long term extension study (up to approximately 156 weeks)
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 Treatment-emergent Adverse Events (TEAEs)
Secondary outcome measures
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104
Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52
Number of Participants with Clinical Remission at Week 104
+14 moreSide effects data
From 2022 Phase 1 trial • 32 Patients • NCT0498733375%
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: Efavaleukin Alfa Dose 3 (High Dose)Experimental Treatment1 Intervention
Participants who were receiving efavaleukin alfa dose 3 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 3.
Group II: Efavaleukin Alfa Dose 2 (Moderate Dose)Experimental Treatment1 Intervention
Participants who were receiving efavaleukin alfa dose 2 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 2.
Group III: Efavaleukin Alfa Dose 1 (Low Dose)Experimental Treatment1 Intervention
Participants who were receiving efavaleukin alfa dose 1 during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive efavaleukin alfa dose 1.
Group IV: PlaceboPlacebo Group1 Intervention
Participants who were receiving the placebo during the dose-finding study (study 20170104) that decided to continue onto this long-term extension study will continue to receive the placebo.
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
1,377,966 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
1,964 Patients Enrolled for Ulcerative Colitis
MDStudy DirectorAmgen
914 Previous Clinical Trials
924,439 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
964 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection requiring IV drugs or hospital stay.I have had or currently have abnormal cell growth in my flat mucosal tissues.I am using corticosteroids for a condition other than ulcerative colitis.I have or had non-cancerous growths that are not typical adenomas.I was diagnosed with a new cancer during my previous study.I am not pregnant, breastfeeding, nor planning to during the study and 6 weeks after.I have or had high-grade abnormal cell growth.I am a woman able to have children and agree to use birth control as required.I agree not to donate eggs during and for 6 weeks after the study.I have a benign tumor that hasn't been removed.I will not get a live vaccine during or up to 6 weeks after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Efavaleukin Alfa Dose 1 (Low Dose)
- Group 3: Efavaleukin Alfa Dose 2 (Moderate Dose)
- Group 4: Efavaleukin Alfa Dose 3 (High Dose)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this trial restricted to individuals younger than 30 or can older adults participate as well?
"The cut-off for enrolment is set at 18 years of age, while the upper threshold is 80."
Answered by AI
Has the United States Food and Drug Administration (FDA) sanctioned Efavaleukin Alfa Dose 1 (Low Dose)?
"The safety of Efavaleukin Alfa Dose 1 (Low Dose) was rated a 2, since it is still in the Phase 2 trial phase and there is some evidence that supports its safety but no proof yet as to its efficacy."
Answered by AI
Is there still room for participants in this medical experiment?
"The clinical trial hosted on clinicaltrials.gov is currently registering participants, which began being accepted since April 28th 2023 and was recently updated on May 8th 2023."
Answered by AI
What is the aggregate number of participants in this clinical experiment?
"That is correct. According to information on clinicaltrials.gov, this clinical trial which was initially posted on April 28th 2023 is actively searching for potential candidates. A total of 200 participants need to be recruited from 3 different medical centres."
Answered by AI
What are the qualifications required to participate in this research?
"This study is seeking to enrol 200 individuals, aged 18-80, who suffer from ulcerative colitis. Furthermore, these participants must have already completed the 52 week endoscopy procedure of phase 2 (20170104) and need to submit a signed consent form before initiation."
Answered by AI
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