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Active (not recruiting) Phase 3 NCT06003426

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Phase 3 – large-scale trial before approval
Conditions: Idiopathic Pulmonary Fibrosis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Who can participate
Inclusion Criteria * Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. * Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. * If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening. * If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. * Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test. * Men who are sexually active with women of childbearing potential agree to use male barrier contraception. Exclusion Criteria * History of stroke or transient ischemic attack within 3 months prior to screening. * Participants who exhibit symptoms of heart failure at rest. * Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Other protocol-defined Inclusion/Exclusion criteria apply
Locations 30
Argentina (1)
Local Institution - 0131
Mar del Plata , Buenos Aires
Australia (1)
Local Institution - 0209
Camperdown , New South Wales
Belgium (1)
Local Institution - 0332
Yvoir , Namur
Brazil (1)
Local Institution - 0084
Belo Horizonte , Minas Gerais
Canada (1)
Local Institution - 0062
Sherwood Park , Alberta
Chile (1)
Local Institution - 0503
Concepción , Biobio
China (1)
Local Institution - 0263
Hefei , AH
Colombia (1)
Local Institution - 0297
Medellín , ANT
Denmark (1)
Local Institution - 0064
Aarhus , Central Jutland
Finland (1)
Local Institution - 0350
Turku , Laensi-Suomen Laeaeni
France (1)
Local Institution - 0047
Bron , Auvergne-Rhône-Alpes
Greece (1)
Local Institution - 0314
Marousi , Attica
Hungary (1)
Local Institution - 0018
Budapest
India (1)
Local Institution - 0430
Ahmedabad , Gujarat
Ireland (1)
Local Institution - 0168
Drogheda , LH
Israel (1)
Local Institution - 0331
Haifa , HA
Italy (1)
Local Institution - 0329
Bologna , BO
Japan (1)
Local Institution - 0107
Chiba , Chiba
Mexico (1)
Local Institution - 0324
Metepec , Edo de Mexico
Netherlands (1)
Local Institution - 0394
Rotterdam , South Holland
Peru (1)
Local Institution - 0220
Lima , LIM
Poland (1)
Local Institution - 0143
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
Local Institution - 0198
Guaynabo , PR
South Korea (1)
Local Institution - 0240
Goyang-si , Gyeonggi-do
Spain (1)
Local Institution - 0093
Santander , CB
Switzerland (1)
Local Institution - 0160
Basel , Canton of Basel-City
Taiwan (1)
Local Institution - 0491
Changhua , CHA
Turkey (1)
Local Institution - 0176
Gümüşhane , Gümüşhane Province
United Kingdom (1)
Local Institution - 0378
Birmingham , BIR
United States (1)
Local Institution - 0189
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Healthy volunteers
No
Start date
14.09.2023
Completion date
04.06.2027
Registry ID
NCT06003426
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.