ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

PHASE3RecruitingINTERVENTIONAL
Enrollment

234

Participants

Timeline

Start Date

September 11, 2024

Primary Completion Date

August 1, 2026

Study Completion Date

December 1, 2028

Conditions
MAC Lung DiseaseTreatment Refractory MAC Lung DiseaseMycobacterium Infections, Nontuberculous
Interventions
DRUG

Clofazimine Inhalation Suspension

Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo.

DRUG

Placebo

Eligible participants will be randomized in a 2:1 ratio to 1 of 2 possible treatment assignments, Clofazimine Inhalation Suspension or Placebo.

Trial Locations (101)

112

RECRUITING

Taipei Veterans General Hospital, Taipei

300

RECRUITING

National Taiwan University Hospital, Hsinchu

807

RECRUITING

Kaohsiung Medical University Hospital, Kaohsiung City

2109

RECRUITING

Macquarie University Clinical Trials Unit, Sydney

3004

RECRUITING

Alfred Health, Melbourne

3977

RECRUITING

Monash University Centre for Inflammatory Diseases, Cranbourne

4032

RECRUITING

The Prince Charles Hospital, Brisbane

4064

RECRUITING

Gallipoli Medical Research Foundation, Greenslopes

4575

RECRUITING

Sunshine Coast University Hospital, Birtinya

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

6000

RECRUITING

Royal Perth Hospital Respiratory Clinic, Perth

10016

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Mount Sinai-National Jewish Respiratory Institute, New York

10032

RECRUITING

Columbia University, New York

10467

RECRUITING

Montefiore Medical Center, The Bronx

11042

RECRUITING

Northwell Health, New Hyde Park

11373

RECRUITING

NYC Health and Hospitals-Elmhurst, Queens

19140

RECRUITING

Temple Lung Center, Philadelphia

19611

RECRUITING

Reading Hospital, West Reading

20007

RECRUITING

Georgetown University Hospital, Washington D.C.

20037

RECRUITING

The George Washington University Medical Faculty Associates, Washington D.C.

21287

RECRUITING

Johns Hopkins University School of Medicine, Baltimore

22903

RECRUITING

UVA Health Infectious Diseases Clinic, Charlottesville

29414

RECRUITING

Low Country Infectious Diseases, Charleston

29425

RECRUITING

Medical University of South Carolina, Charleston

29621

RECRUITING

AnMed Health, Anderson

30342

RECRUITING

Emory University School Of Medicine, Atlanta

31605

RECRUITING

Medster Research, Valdosta

32209

RECRUITING

University of Florida College of Medicine, Jacksonville

32608

RECRUITING

Malcolm Randall Veterans Affairs Medical Center, Gainesville

32789

RECRUITING

Flourish Research, Winter Park

32958

WITHDRAWN

Infectious Diseases Consultants of the Treasure Coast, Sebastian

33331

RECRUITING

Cleveland Clinic, Weston

33401

RECRUITING

Midway Specialty Care Center, West Palm Beach

33620

RECRUITING

University of South Florida, Tampa

33707

RECRUITING

Theia Clinical Research, St. Petersburg

33744

RECRUITING

VA Bay Pines, Bay Pines

33765

RECRUITING

St. Francis Sleep, Allergy & Lung Institute, Clearwater

35294

RECRUITING

University of Alabama at Birmingham School of Medicine, Birmingham

48202

RECRUITING

Henry Ford Hospital, Detroit

52242

RECRUITING

University of Iowa Hospital and Clinics, Iowa City

55905

RECRUITING

Mayo Clinic, Rochester

61469

RECRUITING

Chonnam National University Hospital, Gwangju

63110

RECRUITING

Washington University School of Medicine, St Louis

65201

RECRUITING

University of Missouri, Columbia

66160

RECRUITING

University of Kansas Medical Center, Kansas City

67211

RECRUITING

Infectious Disease Consultants Clinical Research, Wichita

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70115

RECRUITING

Ochsner Clinic Foundation, New Orleans

75246

RECRUITING

North Texas Infectious Diseases Consultants, Dallas

75708

RECRUITING

The University of Texas Health Science Center, Tyler

80206

RECRUITING

National Jewish Health, Denver

90048

RECRUITING

Cedars-Sinai Medical Center, Los Angeles

92663

RECRUITING

Hoag Hospital, Newport Beach

93105

RECRUITING

Santa Barbara Cottage Hospital, Santa Barbara

93701

RECRUITING

University of California San Francisco Fresno, Fresno

94143

RECRUITING

University of California San Francisco, San Francisco

94305

RECRUITING

Stanford University, Stanford

95817

RECRUITING

University of California Davis Medical Center, Sacramento

96813

RECRUITING

University of Hawaii, Honolulu

97239

RECRUITING

Oregon Health & Science University, Portland

407219

RECRUITING

Taichung Veterans General Hospital, Taichung

06030-1225

RECRUITING

UCONN Health, Farmington

06520-8057

RECRUITING

Yale University, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

03756

RECRUITING

Dartmouth-Hitchcock Medical Center, Lebanon

07103

RECRUITING

Rutgers New Jersey Medical School, Newark

27599-7248

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

Unknown

RECRUITING

Concord Repatriation General Hospital, Concord

WITHDRAWN

The Catholic University of Korea Seoul St.Mary's Hospital, Seoul

RECRUITING

National Taiwan University Hospital, Taipei

811-3195

RECRUITING

Aso Iizuka Hospital, Fukuoka

RECRUITING

National Hospital Organization Fukuokahigashi Medical Center, Fukuoka

814-0180

RECRUITING

Fukuoka University Hospital, Fukuoka

818-8502

RECRUITING

Fukuoka University Chikushi Hospital, Fukuoka

837-0911

RECRUITING

National Hospital Organization Omuta National Hospital, Fukuoka

377-0280

RECRUITING

National Hospital Organization Shibukawa Medical Center, Gunma

670-8520

RECRUITING

Himeji Medical Center, Hyōgo

319-1113

RECRUITING

Ibarakihigashi National Hospital, Ibaraki

296-0041

RECRUITING

Kameda Clinic, Kamogawa-shi

227-8501

RECRUITING

SHOWA University Fujigaoka Hospital, Kanagawa

610-0113

RECRUITING

Minami Kyoto Hospital, Kyoto

515-8544

RECRUITING

Matsusaka Municipal Hospital, Matsusaka

980-0873

RECRUITING

Sendai Kousei Hospital, Miyagi

945-8585

RECRUITING

Nishiniigata Chuo Hospital, Niigata

560-8552

RECRUITING

National Hospital Organization - Osaka Toneyama Medical Center, Osaka

180-8610

RECRUITING

Saitama Prefectural Cardiovascular and Respiratory Center, Saitama

RECRUITING

Japanese Red Cross Musashino Hospital, Tokyo

591-8555

RECRUITING

National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai

160-8582

RECRUITING

Keio University Hospital, Shinjuku-ku

434-8511

RECRUITING

National Hospital Organization Tenryu Hospital, Shizuoka

105-8470

RECRUITING

Mutual Aid Associations Toranomon Hospital, Tokyo

143-8541

RECRUITING

Toho University Omori Medical Center, Tokyo

162-8655

RECRUITING

Center Hospital of the National Center for Global Health and Medicine, Tokyo

204-8522

RECRUITING

Japan Anti-Tuberculosis Association Fukujuji Hospital, Tokyo

224-8503

RECRUITING

SHOWA University Northern Yokohama Hospital, Yokohama

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

06591

RECRUITING

The Catholic University of Korea Seoul St.Mary's Hospital, Seoul

Sponsors
All Listed Sponsors
lead

Mannkind Corporation

INDUSTRY

NCT06418711 - ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension | Biotech Hunter | Biotech Hunter