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Anti-infective agent

Clofazimine for Mycobacterium Avium Complex Infection

Phase 2
Recruiting
Led By Kevin Winthrop, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet ATS/IDSA 2007 pulmonary disease criteria
Be older than 18 years old
Must not have
Current usage of medications associated with QT prolongation (see Appendix C for full list of prohibited concomitant medications)
Advanced lung disease (FEV<30%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up promis fatigue 7a short form results examined for change from baseline at 24 weeks

Summary

This trial will test the effectiveness and safety of clofazimine to treat MAC lung disease.

Who is the study for?
Adults over 18 with pulmonary Mycobacterium Avium Complex (MAC) infection, who've had at least two positive MAC sputum cultures in the past year are eligible. They must be able to consent and not have severe lung disease, HIV, active tuberculosis or cancer treatments within a year, high heart rhythm risk (QT prolongation), or use certain drugs.
What is being tested?
The trial is testing clofazimine's effectiveness and safety against a sugar pill for treating MAC lung disease. Participants will randomly receive either clofazimine or a placebo to compare outcomes between the two groups.
What are the potential side effects?
Clofazimine may cause side effects like stomach pain, nausea, skin discoloration and itching. It can also potentially affect heart rhythms and interact with other medications leading to more serious issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung condition meets specific health standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that can affect my heart's rhythm.
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My lung function is severely reduced.
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I am currently being treated for active tuberculosis.
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I have had a lung or other solid organ transplant.
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I have been taking more than 15 mg/day of corticosteroids for over 12 weeks.
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I am currently using inhaled antibiotics like amikacin, tobramycin, or gentamicin.
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I am allergic to or had a severe reaction to clofazimine.
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I have taken specific antibiotics for MAC in the last 3 months.
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I have a lung condition with air-filled spaces caused by an infection.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~promis fatigue 7a short form results examined for change from baseline at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and promis fatigue 7a short form results examined for change from baseline at 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline sputum culture at 24 weeks
Secondary study objectives
Change from Baseline 6 Minute Walk Test at 24 weeks
C-reactive protein
Change from Baseline CT scan at 24 weeks
+10 more

Side effects data

From 2023 Phase 3 trial • 588 Patients • NCT02409290
31%
Metabolism and nutrition disorders
31%
Investigations
9%
Hepatic disorders (SMQ)
9%
Gastrointestinal disorders
9%
Psychiatric disorders
6%
Torsade de pointes/QT prolongation (SMQ)
6%
Hearing and vestibular disorders (SMQ)
6%
Musculoskeletal and connective tissue disorders
3%
Pregnancy, puerperium and perinatal conditions
3%
Vascular disorders
3%
General disorders and administration site conditions
3%
Social circumstances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Regimen A (Long Regimen)
Regimen C (Oral Regimen)
Regimen B (Control Regimen)
Regimen D (6-month Regimen)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: clofazimineExperimental Treatment1 Intervention
Participants receive lamprene
Group II: sugar pillPlacebo Group1 Intervention
Participants receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clofazimine
2022
Completed Phase 4
~2980

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,333 Previous Clinical Trials
5,376,758 Total Patients Enrolled
University of South FloridaOTHER
427 Previous Clinical Trials
192,529 Total Patients Enrolled
The University of Texas Health Science Center at TylerOTHER
14 Previous Clinical Trials
25,560 Total Patients Enrolled
University of ChicagoOTHER
1,059 Previous Clinical Trials
839,651 Total Patients Enrolled
Temple UniversityOTHER
316 Previous Clinical Trials
89,205 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,095 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,942 Previous Clinical Trials
47,793,136 Total Patients Enrolled
National Jewish HealthOTHER
144 Previous Clinical Trials
317,272 Total Patients Enrolled
Kevin Winthrop, MDPrincipal Investigator - Oregon Health and Science University
Oregon Health and Science University

Media Library

Clofazimine (Anti-infective agent) Clinical Trial Eligibility Overview. Trial Name: NCT02968212 — Phase 2
Mycobacterium Avium Complex Infection Research Study Groups: clofazimine, sugar pill
Mycobacterium Avium Complex Infection Clinical Trial 2023: Clofazimine Highlights & Side Effects. Trial Name: NCT02968212 — Phase 2
Clofazimine (Anti-infective agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02968212 — Phase 2
~12 spots leftby Dec 2025
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