Recruiting NCT07219173
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brenipatide, Brenipatide, Placebo.
- Who it may be relevant to
- Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Brazil, Canada, China +7
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma
Overview
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma. Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
Interventions
- Drug Brenipatide
Administered SC - Drug Brenipatide
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment [Time frame: Baseline to Week 52]
Secondary outcome measures (6)
- Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1) [Time frame: Baseline, Week 52]
- Change from Baseline in Patient Reported Health Outcomes [Time frame: Baseline, Week 52]
- Time to First Exacerbation [Time frame: Baseline to Week 52]
- Change from Baseline in Weekly Mean Rescue Medication Use [Time frame: Baseline, Week 52]
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Baseline up to Week 52]
- Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs) [Time frame: Baseline to Week 52]
Eligibility criteria
Inclusion criteria
- Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
- Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
- History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.
Exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
- An established diagnosis of occupational asthma
- Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
- chronic respiratory infection
- bronchiectasis
- pulmonary fibrosis
- allergic bronchopulmonary aspergillosis
- emphysema
- chronic bronchitis
- eosinophilic granulomatosis with polyangiitis
- chronic obstructive pulmonary disease, and
- other mimics of asthma, that is, vocal cord dysfunction.
- Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- AMR Clinical — Tempe
- NewportNativeMD, Inc. — Newport Beach
- California Medical Research Associates — Northridge
- Peninsula Research Associates — Rolling Hills Estates
- Asthma & Allergy Associates - Colorado Springs — Colorado Springs
- AMR Clinical — Doral
- Renstar Medical Research — Ocala
- Avanza Medical Research Center — Pensacola
- … and 9 more centers
China · 13 centers
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Scie — Baotou
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
- West China Hospital, Sichuan University — Chengdu
- The First Affiliated Hospital of Chongqing Medical University — Chongqing
- Zhejiang Provincial People's Hospital — Hangzhou
- Jiangxi Provincial People's Hospital — Nanchang
- Nanjing Medical University - Nanjing Jiangning Hospital — Nanjing
- Shanghai General Hospital — Shanghai
- … and 5 more centers
Japan · 12 centers
Center list to be confirmed — check the primary protocol.
Argentina · 10 centers
- Consultorios Médicos, Organización del Buen Ayre S.R.L. — Buenos Aires
- Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
- Fundación Respirar — Buenos Aires
- IDIM - Instituto de Investigaciones Metabólicas — Ciudad de Buenos Aires
- Instituto de Asma, Alergia y Enfermedades Respiratorias — Corrientes
- Centro de Investigaciones Clínicas Baigorria — Granadero Baigorria
- Instituto de Investigaciones Clínicas Mar del Plata — Mar del Plata
- Instituto Médico Río Cuarto — Río Cuarto
- … and 2 more centers
Brazil · 10 centers
- NewData Clinical Research - Aracaju — Aracaju
- Private Practice - Dr. Nelson Rosário — Curitiba
- Clinica de Pneumologia — Goiânia
- Centro de Pesquisa Clínica de Marília - CPCLIM — Marília
- Hospital Universitário Onofre Lopes — Natal
- Instituto Atena de Pesquisa Clinica — Natal
- Instituto Méderi de Pesquisa e Saúde — Passo Fundo
- Hospital de Clínicas de Ribeirão Preto — Ribeirão Preto
- … and 2 more centers
Canada · 10 centers
- Dynamic Drug Advancement — Ajax
- Heritage Medical Research Clinic — Calgary
- St. Joseph's Healthcare Hamilton — Hamilton
- Kelowna Health and Memory Centre — Kelowna
- McGill University Health Centre — Montreal
- IUCPQ — Québec
- Richmond Clinical Trials — Richmond
- C.I.C. Saint-Laurent — Saint-Laurent
- … and 2 more centers
France · 10 centers
- Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Ai — Aix-en-Provence
- CHRU de Brest — Brest
- Centre Hospitalier de Cholet — Cholet
- Centre Hospitalier de Versailles André Mignot — Le Chesnay
- Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre — Le Kremlin-Bicêtre
- Groupe Hospitalier Intercommunal Le Raincy-Montfermeil — Montfermeil
- Hôpital Bichat - Claude-Bernard — Paris
- CHU Bordeaux Haut-Leveque — Pessac
- … and 2 more centers
India · 10 centers
- Galaxy Superspeciality Hospital — Aurangabad
- … and 9 more centers
Mexico · 10 centers
Center list to be confirmed — check the primary protocol.
Germany · 9 centers
- KPPK Studienzentrum — Bendorf
- Studienpraxis Berlin-Brandenburg Lennart Schaper — Berlin
- Ambulantes Lungenzentrum Essen — Essen
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen — Essen
- IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinolo — Frankfurt
- ME Clinical Respiratory Research Hamburg — Hamburg
- POIS Sachsen — Leipzig
- IKF Pneumologie Mainz — Mainz
- … and 1 more center
Netherlands · 6 centers
Center list to be confirmed — check the primary protocol.
Poland · 4 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07219173 · 27744 · 2025-522640-41 · J2S-MC-GZMR