Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

NCT06120140 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 61186372NSC20072023-505863-35-00
• Study Type: interventional
• Target: 305
• Locations: 11 countries
• Sites: 93

Brief Summary

The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (\>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care skin management and with modified enhanced dermatologic management in participants with locally advanced or metastatic stage IIIB/C-IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) treated first-line with amivantamab and lazertinib. The study also includes Expansion cohorts (in 2 different schedules) to evaluate enhanced dermatologic management and early intervention for DAEIs or paronychia, in participants receiving subcutaneous amivantamab and lazertinib. A substudy will enroll participants from Arms A and B who experience specific new-onset or persistent DAEIs (Grade \>=2) during treatment with intravenous (IV) amivantamab and lazertinib. This substudy aims to assess the reactive use of dermatologic treatment strategies in these participants.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade Greater Than or Equal to (>=) 2 Dermatologic Adverse Events of Interest (DAEIs) Within 12 Weeks After Initiation of Anticancer Treatment

  Number of participants with Grade \>= 2 DAEIs within 12 weeks after initiation of anticancer treatment based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0 will be reported. DAEIs includes rash, dermatitis acneiform, pruritus, skin fissures, acne, folliculitis, erythema, eczema, rash maculo-papular, skin exfoliation, skin lesion, skin irritation, dermatitis, rash erythematous, rash macular, rash popular, rash pruritic, rash pustular, dermatitis contact, dermatitis exfoliative generalized, drug eruption, dyshidrotic eczema, eczema asteatotic and paronychia. As per NCI CTCAE v 5.0, severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

  Up to 12 weeks after initiation of anticancer treatment

Secondary Outcomes (21)

• Number of Participants With DAEIs by Severity Based on NCI-CTCAE v 5.0

  Up to 12 weeks after initiation of anticancer treatment

• Number of Participants With Grade >=2 DAEIs Within 6 Months After Initiation of Anticancer Treatment Based on NCI-CTCAE v 5.0

  Up to 6 months after initiation of anticancer treatment

• Number of Grade >= 2 DAEI Per Participants

  Up to 12 months

• Time to First Occurrence of Grade >=2 DAEI

  Up to 12 months

• Time to Resolution of Grade >= 2 DAEI

  Up to 12 months

Other Outcomes (1)

• Percentage of Participants Achieving Best Response for the Dermatologic Adverse Event

  Up to 12 weeks

Study Arms (6)

Arm A: Enhanced Dermatologic Management

EXPERIMENTAL

Participants will receive enhanced dermatologic management to reduce toxicities in skin and nail with doxycycline tablet or minocycline capsule, clindamycin topical lotion, chlorhexidine topical solution, and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab intravenously (Dose 1 for body weight \[BW\] less than 80 kilograms \[kg\] and Dose 2 for BW greater than or equal to \[\>=\] 80 kg as IV infusion \[Arm A\]) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1).

Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer

Arm B: Standard-of-Care Dermatologic Management

ACTIVE COMPARATOR

Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab administered as IV infusion plus lazertinib, dose and dosing schedule as same as experimental arm.

Drug: Amivantamab IV; Drug: Lazertinib; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer

Sub-study: Cohort A: Ruxolitinib

EXPERIMENTAL

Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade greater than or equal to \[\>=\] 2, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0) will be enrolled and receive reactive treatment with ruxolitinib in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.

Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Ruxolitinib

Sub-study: Cohort B: Tacrolimus

EXPERIMENTAL

Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade \>= 2, as defined by NCI-CTCAE v5.0) will be enrolled and receive reactive treatment with tacrolimus in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.

Drug: Amivantamab IV; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Clindamycin; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Tacrolimus

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

EXPERIMENTAL

Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per standard schedule. If a participant develops a dermatologic adverse event of interest (DAEI) they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.

Drug: Amivantamab SC; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline; Drug: Chlorhexidine; Other: Noncomedogenic skin moisturizer; Other: Ruxolitinib; Drug: Zinc gluconate; Drug: Propranolol; Drug: Timolol; Drug: Clobetasol

Amivantamab SC Expansion Cohort: Modified Schedule

EXPERIMENTAL

Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib as per modified schedule. If a participant develops a DAEI they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1.

Drug: Amivantamab SC; Drug: Lazertinib; Drug: Doxycycline; Drug: Minocycline

Interventions

Amivantamab IV DRUG

Amivantamab will be administered.

Also known as: JNJ-61186372

Arm A: Enhanced Dermatologic Management; Arm B: Standard-of-Care Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Amivantamab SC DRUG

Amivantamab will be administered as SC injection.

Also known as: JNJ-61186372

Amivantamab SC Expansion Cohort: Modified Schedule; Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

Lazertinib DRUG

Lazertinib tablet will be administered orally.

Also known as: JNJ-73841937

Amivantamab SC Expansion Cohort: Modified Schedule; Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Arm A: Enhanced Dermatologic Management; Arm B: Standard-of-Care Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Doxycycline DRUG

Doxycycline tablet will be administered orally.

Amivantamab SC Expansion Cohort: Modified Schedule; Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Arm A: Enhanced Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Zinc gluconate DRUG

Zinc gluconate tablet will be administered.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

Propranolol DRUG

Propranolol tablet will be administered.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

Timolol DRUG

Timolol will be used to the affected skin area.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

Clobetasol DRUG

Clobetasol shampoo will be used on the scalp.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule

Minocycline DRUG

Minocycline capsule will be administered orally.

Amivantamab SC Expansion Cohort: Modified Schedule; Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Arm A: Enhanced Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Clindamycin DRUG

Clindamycin lotion will be used as topical application on the scalp.

Arm A: Enhanced Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Chlorhexidine DRUG

Chlorhexidine solution will be used as topical application on hands and feet.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Arm A: Enhanced Dermatologic Management; Arm B: Standard-of-Care Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Noncomedogenic skin moisturizer OTHER

Noncomedogenic skin moisturizer will be used as topical application.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Arm A: Enhanced Dermatologic Management; Arm B: Standard-of-Care Dermatologic Management; Sub-study: Cohort A: Ruxolitinib; Sub-study: Cohort B: Tacrolimus

Ruxolitinib OTHER

Ruxolitinib will be used to the affected skin area.

Amivantamab Subcutaneous (SC) Expansion Cohort: Standard Schedule; Sub-study: Cohort A: Ruxolitinib

Tacrolimus OTHER

Tacrolimus will be used as topical application to the affected skin area.

Sub-study: Cohort B: Tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC); Is treatment naive and not amenable to curative therapy including surgical resection or (chemo) radiation. Adjuvant or neoadjuvant therapy for Stage I, Stage II or Stage IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease
• Have a tumor that harbors an epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard-of-care
• A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants with a history of symptomatic brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 milligram (mg) prednisone or equivalent daily for the treatment of intracranial disease
• Can have prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints, safety, or the efficacy of the study treatment(s). For the amivantamab SC expansion cohorts: Due to the increased risk of skin cancer with ruxolitinib, participants with any prior or concurrent skin malignancies will be excluded
• Sub-study: Participants must have new-onset or persistent (defined as non-responsive to standard of care \[SoC\]) Grade \>=2 specific DAEIs of the scalp, face, or body, as defined by NCI-CTCAE Grading v5.0 for DAEIs (excluding paronychia)

You may not qualify if:

• History of uncontrolled illness, including but not limited to uncontrolled diabetes; ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \[participants will be required to complete antibiotics 1 week prior to starting background anticancer treatment\] or diagnosed or suspected viral infection). For the amivantamab SC expansion cohorts, this includes active localized serious infections; active bleeding diathesis; impaired oxygenation requiring continuous oxygen supplementation; refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of background anticancer treatment or doxycycline/minocycline; psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements; any ophthalmologic condition that is clinically unstable; pre-existing skin condition that would prevent adequate evaluations of dermatologic toxicity, as determined by the investigator
• Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
• Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab, lazertinib, or to tetracyclines, doxycycline, minocycline, timolol\*, ruxolitinib\*, zinc\*, corticosteroids\* or their excipients or to any component of the enhanced dermatologic management (\*for the amivantamab SC expansion cohorts)
• Participant has received any prior systemic treatment at any time for locally advanced stage III B/C or metastatic stage IV disease (adjuvant or neoadjuvant therapy for stage I, II or IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease)
• Participant has an active or past medical history of leptomeningeal disease
• Sub-study: Participants who have received prior treatment for epidermal growth factor receptor (EGFR)-induced DAEIs with JAK inhibitors (for Cohort A) or calcineurin inhibitors (for Cohort B)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (93)

Ironwood Cancer and Research Center

Chandler, Arizona, 85224, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Providence Fullerton

Fullerton, California, 92835, United States

Location

Los Angeles Cancer Network

Glendale, California, 91204, United States

Location

City of Hope Seacliff

Huntington Beach, California, 92648, United States

Location

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

Location

City of Hope Long Beach Elm

Long Beach, California, 90813, United States

Location

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

USC Norris Oncology Hematology Newport Beach

Newport Beach, California, 92663, United States

Location

Kaiser Permanente Oakland Medical Center

Oakland, California, 94611, United States

Location

Kaiser Permanente Roseville Medical Center

Roseville, California, 95661, United States

Location

Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Kaiser Permanente Northern California

Vallejo, California, 94589, United States

Location

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

Location

University Cancer & Blood Center

Athens, Georgia, 30607, United States

Location

Hope and Healing Care

Hinsdale, Illinois, 60521, United States

Location

Oncology Hematology Associates

Springfield, Missouri, 65807, United States

Location

Renown Health Medical Oncology

Reno, Nevada, 89502, United States

Location

Hunterdon Hematology Oncology

Flemington, New Jersey, 08822, United States

Location

Clinical Research Alliance Inc

Westbury, New York, 11590, United States

Location

Regional Medical Oncology Center

Wilson, North Carolina, 27893, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

Gundersen Health System

West Salem, Wisconsin, 54669, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1199, Argentina

Location

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, C1122, Argentina

Location

Centro Medico Austral

Capital Federal, C1017, Argentina

Location

Hospital Italiano de La Plata

La Plata, B1900AXI, Argentina

Location

Hospital Privado de la Comunidad

Mar del Plata, B7602, Argentina

Location

CTO Centro De Tratamento Oncologico LTDA

Belém, 66.073-005, Brazil

Location

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, 30150-221, Brazil

Location

Liga Paranaense de Combate ao Cancer

Curitiba, 81520-060, Brazil

Location

Fundacao Doutor Amaral Carvalho

Jaú, 17.210-080, Brazil

Location

Hospital Nossa Senhora da Conceicao S A

Porto Alegre, 91350 200, Brazil

Location

Nucleo de Oncologia da Bahia Oncoclinicas

Salvador, 40170 070, Brazil

Location

Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, 96835-100, Brazil

Location

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246 000, Brazil

Location

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900, Brazil

Location

Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate

Taubaté, 12030-200, Brazil

Location

Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia

Vitória, 29043-260, Brazil

Location

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

Location

West China Hospital

Chengdoucun, 610041, China

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080, China

Location

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, 310003, China

Location

Harbin medical university cancer hospital

Harbin, 150040, China

Location

Huizhou Municipal Central Hospital

Huizhou, 516001, China

Location

Zhongda Hospital Southeast University

Nanjing, 210000, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Hopital Nord

Marseille, 13915, France

Location

Hopital PASTEUR

Nice, 06001, France

Location

Institut Curie

Paris, 75005, France

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, 35392, Germany

Location

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Klinikum Kassel GmbH

Kassel, 34125, Germany

Location

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105, Germany

Location

Hospital Pulau Pinang

George Town, 10450, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Hospital Umum Sarawak

Kuching, 93586, Malaysia

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Gral. Univ. de Alicante

Alicante, 03010, Spain

Location

Hosp. Univ. Quiron Dexeus

Barcelona, 08028, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. de Jaen

Jaén, 23007, Spain

Location

Hosp. Univ. Lucus Augusti

Lugo, 27003, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29010, Spain

Location

Hosp. Ntra. Sra. de Valme

Seville, 41014, Spain

Location

National Taiwan University Hospital Hsin Chu Branch

Hsinchu, 30059, Taiwan

Location

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan City, 333, Taiwan

Location

Adana City Hospital

Adana, 1060, Turkey (Türkiye)

Location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, 6800, Turkey (Türkiye)

Location

Bakirkoy Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

I A U VM Medical Park Florya Hastanesi

Istanbul, 34295, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Ondokuz Mayis University

Samsun, 55420, Turkey (Türkiye)

Location

Related Publications (1)

• Cho BC, Li W, Spira AI, Sauder M, Feldman J, Bozorgmehr F, Mak M, Smith J, Voon PJ, Liu B, Tian P, Tan JL, Yang CT, Shih JY, Karadurmus N, Cundom JE, Bertollo G, Cicin I, Nieva J, Ortega-Granados AL, Tomasini P, Nguyen D, Felip E, Schuchard J, Murphy SP, Anderson BG, Romero T, Xia Y, Sheng S, Bauml JM, Mahadevia PJ, Kam J, Nematian-Samani M, Simoes J, Wildgust M, Girard N. Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial. J Thorac Oncol. 2025 Oct;20(10):1517-1530. doi: 10.1016/j.jtho.2025.07.117. Epub 2025 Sep 9.

  PMID: 40923969 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

amivantamab; lazertinib; Doxycycline; Minocycline; Clindamycin; Chlorhexidine; ruxolitinib; Tacrolimus; gluconic acid; Propranolol; Timolol; Clobetasol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Biguanides; Guanidines; Amidines; Macrolides; Lactones; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Morpholines; Oxazines; Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): January 31, 2032
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (11); BR (11); US (28); TW (5); MY (4); ES (9); DE (6); AR (5); FR (3); TU (8); KR (3)