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Safety and Efficacy of Efavaleukin Alfa in Subjects With Active Rheumatoid Arthritis

NCT03410056 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-06-22

Study results available
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Summary

Phase 1b. To evaluate the safety and tolerability of subcutaneous (SC) dose administrations of Efavaleukin alfa in subjects with active rheumatoid arthritis (RA).

Phase 2a. To evaluate the efficacy of Efavaleukin alfa at week 12 as measured by the American College of Rheumatology 20 percent improvement criteria (ACR 20) in adult subjects with moderate to severe RA.

Conditions

  • Rheumatoid Arthritis RA

Interventions

DRUG

Efavaleukin alfa

Efavaleukin alfa administered as a subcutaneous injection.

DRUG

Placebo

Placebo administered as a subcutaneous injection.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2019-12-10
Completion
2020-05-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03410056 on ClinicalTrials.gov