A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
A legfontosabb adatok
- Hol
- Ann Arbor, Atlanta, Augusta, Aurora, Austin, Baltimore, Boston, Boynton Beach, Chicago, Cincinnati, Cleveland, Denver, Gainesville, Houston, Iowa City, Irvine, Irving, Jackson, Jacksonville, Kansas City, Los Angeles, Manhasset, Marietta, Minneapolis, New Orleans, New York, Oklahoma City, Philadelphia, Phoenix, Pittsburgh, Plantation, Portland, Rochester, San Francisco, Scottsdale és Tampa (Egyesült Államok)Mind a 36 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Ann Arbor, MichiganHospital not named in the registryNo longer taking part
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Augusta, GeorgiaHospital not named in the registryNo longer taking part
- Aurora, ColoradoHospital not named in the registryNo longer taking part
- Austin, TexasHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Boynton Beach, FloridaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Denver, ColoradoHospital not named in the registryNo longer taking part
- Gainesville, FloridaHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- Iowa City, IowaHospital not named in the registryNo longer taking part
- Irvine, CaliforniaHospital not named in the registryNo longer taking part
- Irving, TexasHospital not named in the registryNo longer taking part
- Jackson, MississippiHospital not named in the registryNo longer taking part
- Jacksonville, FloridaHospital not named in the registryNo longer taking part
- Kansas City, MissouriHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Manhasset, New YorkHospital not named in the registryNo longer taking part
- Marietta, GeorgiaHospital not named in the registryNo longer taking part
- Minneapolis, MinnesotaHospital not named in the registryNo longer taking part
- New Orleans, LouisianaHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Oklahoma City, OklahomaHospital not named in the registryNo longer taking part
- Philadelphia, PennsylvaniaHospital not named in the registryNo longer taking part
- Phoenix, ArizonaHospital not named in the registryNo longer taking part
- Pittsburgh, PennsylvaniaHospital not named in the registryNo longer taking part
- Plantation, FloridaHospital not named in the registryNo longer taking part
- Portland, OregonHospital not named in the registryNo longer taking part
- Rochester, MinnesotaHospital not named in the registryNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryNo longer taking part
- Scottsdale, ArizonaHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- Priovant Therapeutics, Inc.
- Azonosító
- NCT05437263EU 2022-500367-12-00
- A regiszteradat frissítve
- 2026. szeptember 15.
- Eredeti leírás
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.
Bevonási feltételek: A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies; Adult subjects (18-75 years old); Active muscle and skin disease at screening and baseline; Prior therapy OR current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant; Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2.
Kizáró feltételek: History of:; Any lymphoproliferative disorder; Active malignancy; History of cancer within 5 years prior to randomization (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.); Cancer-associated dermatomyositis; Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome); Participants at a risk of thrombosis or cardiovascular disease; Participants with active or recent infections; Dermatomyositis with end-stage organ involvement; Dermatomyositis with irreversible muscle involvement; Participants with a high risk for herpes zoster reactivation.