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Cytokine

Efavaleukin Alfa for Graft-versus-Host Disease

Phase 1 & 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 day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks
Awards & highlights

Study Summary

This trial is testing a new drug to treat people with a certain type of cancer who have not responded well to other treatments.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 until the end of study; median (min, max) duration was 38.01 (3.27, 139.81) 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
Phase 1b: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Phase 1b: Number of Participants Who Experienced a Treatment-emergent AE
Phase 1b: Number of Participants Who Experienced a Treatment-emergent Serious AE
+1 more
Secondary outcome measures
Phase 2: Changes in quality of life
Phase 2: Changes in symptom burden over time
Phase 2: Failure free survival rate
+1 more

Side effects data

From 2021 Phase 1 trial • 35 Patients • NCT03451422
60%
Injection site erythema
40%
Dry mouth
40%
Asthenia
40%
Erythema
40%
Fatigue
40%
Injection site reaction
40%
Non-cardiac chest pain
20%
Upper respiratory tract infection
20%
Vomiting
20%
Blood pressure decreased
20%
Decreased appetite
20%
Body temperature increased
20%
Dysphagia
20%
Injection site pruritus
20%
Spinal pain
20%
Depression
20%
Dry skin
20%
Rash
20%
Injection site warmth
20%
Skin papilloma
20%
Hypertension
20%
Psychomotor hyperactivity
20%
Bowel movement irregularity
20%
Dyspepsia
20%
Nausea
20%
Reflux gastritis
20%
Injection site inflammation
20%
Injection site mass
20%
Injection site rash
20%
Back pain
20%
Musculoskeletal chest pain
20%
Dizziness
20%
Presyncope
20%
Sciatica
20%
Sleep disorder
20%
Pollakiuria
20%
Oropharyngeal pain
20%
Petechiae
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AMG 592 Cohort 1
AMG 592 Cohort 2
AMG 592 Cohort 3
AMG 592 Cohort 4
AMG 592 Cohort 5

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: RP2D Efavaleukin AlfaExperimental Treatment1 Intervention
The phase 2 portion of this study will be conducted as a single arm, multi-center, open label trial in subjects with steroid refractory chronic graft versus Host Disease (cGVHD). All subjects will receive the recommended phase 2 dose (RP2D) of efavaleukin alfa for up to 52 weeks plus protocol permitted background therapy for cGVHD. Due to early study termination the Phase 2 portion of the study was never opened.
Group II: Phase 1: Efavaleukin Alfa Multiple Ascending DosesExperimental Treatment1 Intervention
Efavaleukin will be administered as multiple ascending doses (MAD) across cohorts 1-5. Each dosing cohort will consist of between 3 and 6 subjects who will receive efavaleukin alfa subcutaneously (SC) either every week or every 2 weeks plus protocol permitted background therapy for 52 weeks. At the discretion of the Sponsor, following discussion and agreement between the principal investigator and medical monitor, subjects responding to efavaleukin alfa (as assessed by the end of week 50), who wish to continue treatment, may continue to receive efavaleukin alfa treatment at their current dosing regimen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efavaleukin Alfa
2018
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,369 Previous Clinical Trials
1,377,561 Total Patients Enrolled
MDStudy DirectorAmgen
912 Previous Clinical Trials
923,957 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
2018. "Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03422627.
~5 spots leftby Apr 2025
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