A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
Completed · Phase 2 · NCT06280391
Conditions: Bronchiectasis
At a glance
- Research payments reported, 2025
- $2.0M
- U.S. investigators named
- 28
- Sites paid
- 27
- Planned or actual enrollment
- 314
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab (SAR440340) (drug), Placebo (drug)
- Dates
- Started 2024-02-20; completion 2026-02-02
- Results posted
- Yes
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study was to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) was up to 47-77 weeks * The treatment duration was up to 24-52 weeks * The follow-up duration was 20 weeks * Site/phone visits were at a monthly interval
From ClinicalTrials.gov, last updated 2026-10-07. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $2.0M in research payments for this study in 2025 (184 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Da-wei Liao, MD Pulmonology · Phoenix, AZ
- Robert R. Orr, D.O. Pulmonology · Peoria, AZ
- David N. Pham, MD Pulmonology · Westminster, CA
- Andrew S. Wachtel, M.D. Pulmonology · Los Angeles, CA
- Ashley J. Losier, M.D. Pulmonology · New Haven, CT
- Jaime Avecillas, MD Pulmonology · Miami, FL
- Peter A. Bercz, M.D. Pulmonology · Pensacola, FL
- Maria Campos-yatzkan, M.D Pulmonology · Miami, FL
- Frank P. Hull, MD Pulmonology · Plantation, FL
- Carlos M. Martinez, MD Pulmonology · Homestead, FL
- Neal Warshoff, D.O. Pulmonology · Loxahatchee, FL
- Marc A. Sala, MD Critical Care Medicine · Chicago, IL
- Andreas Schmid, MD Pulmonology · Kansas City, KS
- Shijing Jia, M.D. Pulmonology · Ann Arbor, MI
- Oscar F. Parodi Ortiz De Villate, M.D. Pulmonology · Warren, MI
- Shail B. Mehta, MD Pulmonology · Saint Louis, MO
- Reginald J. Fowler JR., MD Critical Care Medicine · Winston-salem, NC
- Doreen Addrizzo-harris, MD Pulmonology · New York, NY
- Sandeep Bansal, MD Pulmonology · Du Bois, PA
- Gerard Criner, MD Pulmonology · Philadelphia, PA
- Daniel J. Dorgan, MD Critical Care Medicine · Philadelphia, PA
- Michael B. Denenberg, M.D. Pulmonology · Rock Hill, SC
- Patrick A. Flume, MD Pulmonology · Charleston, SC
- Subodh K. Bhuchar, MD Family Medicine · Sugar Land, TX
- Eduardo E. Chang Pulmonology · The Woodlands, TX
- Megan S. Devine, MD Pulmonology · Tyler, TX
- Shahrukh A. Kureishy, MD Pulmonology · Mckinney, TX
- Pamela J. Mcshane, M.D. Pulmonology · Tyler, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- New York University NYU Grossman School of Medicine An Administrative Unit of New York University $259,313
- Allianz Research Institute Co Llc $246,990
- University of Michigan Health System, MI $186,564
- Metroplex Pulmonary and Sleep Center $155,199
- Washington University $131,266
- Hull Hull Medical Specialists LLP Broward Pulmonary and Sleep Specialists $111,384
- Yale Univeristy $95,943
- Advanced Pulmonary Research Institute of Michigan PLLC $95,213
- Pensacola Research Consultants Inc Avanza Medical Research Center $89,522
- University of Texas Health Science Center at Tyler, TX $80,952
- Pact Center for Research PLLC $63,560
- Hospital of Univ of Pennsylvania, PA $57,894
- Medical University of South Carolina $57,065
- Allianz Research Institute Inc $54,700
- Northwestern University $44,825
- Southern California Inst for Respiratory Diseases Inc $40,622
- Advanced Pulmonary Research Institute $38,600
- Temple University of the Commonwealth System of Higher Education $32,107
- University of Kansas Medical Center Research Inst Inc $29,448
- Southeastern Research Center LLC $28,623
- Clinical Research Associates of Central PA LLC $24,152
- High Quality Research Inc $17,229
- Phoenix Medical Group, PC $12,800
- Lcc Medical Research Institute Llc $6,500
- Clinical Research of Rock Hill Clinical Research of the Carolinas $4,470
- Pioneer Research Solutions Houston Stancliff Road $2,250
- Destiny Research Center $600
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.