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A Phase II Study of M2951 in SLE

NCT02975336 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 469

Last updated 2021-04-12

Study results available
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Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Conditions

Interventions

DRUG

Placebo

Participants received placebo matched to M2951 orally for 52 weeks.

DRUG

M2951

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.

DRUG

M2951

Participants received 75 mg of M2951 orally QD for 52 weeks.

DRUG

M2951

Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.

DRUG

M2951

Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc., a business of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2019-11-27
Completion
2020-03-23

Countries

  • United States
  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Germany
  • Italy
  • Japan
  • Malaysia
  • Mauritius
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02975336 on ClinicalTrials.gov