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Interleukin-2 (IL-2) Agonist

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

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.

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.

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 ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of Participants with Corticosteroid-free Remission

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%

Vision blurred

13%

Pain in extremity

13%

Nasal congestion

13%

Injection site pain

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: 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

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