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NCT03422627 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease

A Phase 1 study, sponsored by Amgen.

Terminated
Registry status
Phase 1
Development phase
32
Enrollment target

NCT03422627 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 32 participants.

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The verdict

NCT03422627, a Phase 1 study, was terminated before completion, sponsored by Amgen.

TERMINATED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall response rate (ORR) at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria. Due to early termination, the Phase 2 portion of this study was not conducted.

Interventions

  • DRUG Efavaleukin Alfa

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2018-04-27
Est. Completion 2022-10-13
Phase Phase 1

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT03422627

The ClinicalTrials.gov registry entry for NCT03422627 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Efavaleukin Alfa is the first listed.

NCT03422627 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03422627 about?

NCT03422627 is a clinical study titled "Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease". Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD). Phase 2: To evaluate the efficacy of efavaleukin alfa in subjects with steroid refractory cGVHD as measured by overall res...

What is the current status of trial NCT03422627?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-04-27. Estimated completion is 2022-10-13.

What interventions are being tested in trial NCT03422627?

The interventions under investigation include: Efavaleukin Alfa (DRUG).

Who is sponsoring clinical trial NCT03422627?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.