ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
Public ClinicalTrials.gov record NCT06418711. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazimine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
Study identification
- NCT ID
- NCT06418711
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 132 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 11, 2024 (Actual)
- Primary completion
- Nov 10, 2025 (Actual)
- Completion
- Nov 10, 2025 (Actual)
- Last update posted
- Nov 12, 2025
2024 – 2025
United States locations
- U.S. sites
- 54
- U.S. states
- 26
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35294 | — |
| University of California San Francisco Fresno | Fresno | California | 93701 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Hoag Hospital | Newport Beach | California | 92663 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | — |
| Stanford University | Stanford | California | 94305 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| UCONN Health | Farmington | Connecticut | 06030-1225 | — |
| Yale University | New Haven | Connecticut | 06520-8057 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| The George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| VA Bay Pines | Bay Pines | Florida | 33744 | — |
| St. Francis Sleep, Allergy & Lung Institute | Clearwater | Florida | 33765 | — |
| Malcolm Randall Veterans Affairs Medical Center | Gainesville | Florida | 32608 | — |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| Theia Clinical Research | St. Petersburg | Florida | 33707 | — |
| University of South Florida | Tampa | Florida | 33620 | — |
| Midway Specialty Care Center | West Palm Beach | Florida | 33401 | — |
| Cleveland Clinic | Weston | Florida | 33331 | — |
| Flourish Research | Winter Park | Florida | 32789 | — |
| Emory University School Of Medicine | Atlanta | Georgia | 30342 | — |
| Medster Research | Valdosta | Georgia | 31605 | — |
| University of Hawaii | Honolulu | Hawaii | 96813 | — |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Infectious Disease Consultants Clinical Research | Wichita | Kansas | 67211 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70115 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Missouri | Columbia | Missouri | 65201 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Northwell Health | New Hyde Park | New York | 11042 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Mount Sinai-National Jewish Respiratory Institute | New York | New York | 10029 | — |
| Columbia University | New York | New York | 10032 | — |
| NYC Health and Hospitals-Elmhurst | Queens | New York | 11373 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7248 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Temple Lung Center | Philadelphia | Pennsylvania | 19140 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| Low Country Infectious Diseases | Charleston | South Carolina | 29414 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | — |
| The University of Texas Health Science Center | Tyler | Texas | 75708 | — |
| UVA Health Infectious Diseases Clinic | Charlottesville | Virginia | 22903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06418711, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 12, 2025 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06418711 live on ClinicalTrials.gov.