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Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness for Patients With Systemic Sclerosis With Interstitial Lung Disease

NCT01559129 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-12-01

Study results available
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Summary

The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.

Conditions

Interventions

DRUG

Pomalidomide (CC-4047)

1 mg orally every day for 52 weeks

DRUG

Placebo

Matching placebo capsules taken orally once a day

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Shimon Korish, MD · Celgene Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-09
Primary Completion
2016-11-03
Completion
2016-11-03

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • Poland
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

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 NCT01559129 on ClinicalTrials.gov