Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
A legfontosabb adatok
- Hol
- Ada, Albany, Atlanta, Baltimore, Birmingham, Boston, Charleston, Chicago, Cincinnati, Cleveland, Dallas, Denver, Detroit, Dickson, Durham, Falls Church, Gainesville, Greenville, Houston, Jackson, Los Angeles, Louisville, Middletown, Minneapolis, New Orleans, Oklahoma City, Philadelphia, Phoenix, Portland, Richmond, Rochester, Sacramento, Salt Lake City, St Louis, Tampa, Washington D.C. és Weston (Egyesült Államok)Mind a 37 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Ada, MichiganHospital not named in the registryNo longer taking part
- Albany, New YorkHospital not named in the registryNo longer taking part
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Birmingham, AlabamaHospital not named in the registryNo longer taking part
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Charleston, South CarolinaHospital 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
- Dallas, TexasHospital not named in the registryNo longer taking part
- Denver, ColoradoHospital not named in the registryNo longer taking part
- Detroit, MichiganHospital not named in the registryNo longer taking part
- Dickson, TennesseeHospital not named in the registryNo longer taking part
- Durham, North CarolinaHospital not named in the registryNo longer taking part
- Falls Church, VirginiaHospital not named in the registryNo longer taking part
- Gainesville, FloridaHospital not named in the registryNo longer taking part
- Greenville, North CarolinaHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- Jackson, MississippiHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Louisville, KentuckyHospital not named in the registryNo longer taking part
- Middletown, New YorkHospital 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
- 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
- Portland, OregonHospital not named in the registryNo longer taking part
- Richmond, VirginiaHospital not named in the registryNo longer taking part
- Rochester, MinnesotaHospital not named in the registryNo longer taking part
- Sacramento, CaliforniaHospital not named in the registryNo longer taking part
- Salt Lake City, UtahHospital not named in the registryNo longer taking part
- St Louis, MissouriHospital not named in the registryNo longer taking part
- Tampa, FloridaHospital not named in the registryNo longer taking part
- Washington D.C., District of ColumbiaHospital not named in the registryNo longer taking part
- Weston, FloridaHospital not named in the registryNo longer taking part
A vizsgálat adatai
- Ki végzi
- aTyr Pharma, Inc.
- Azonosító
- NCT05415137EU 2023-506039-13-00
- A regiszteradat frissítve
- 2026. június 4.
- Eredeti leírás
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy.
Bevonási feltételek: Documented history of pulmonary sarcoidosis for at least 6 months, supported by the following evidence: documented histologically proven diagnosis of sarcoidosis by tissue biopsy and documented evidence of parenchymal lung involvement by historical radiological evidence; Evidence of symptomatic pulmonary sarcoidosis, as demonstrated by the following criteria: Modified Medical Research Council (MRC) dyspnea scale grade of at least 1 and KSQ-Lung score ≤70; Patients must be receiving treatment with OCS of ≥ 3 months at Day 1 with a starting dose between ≥ 7.5 and ≤ 25 mg/day ≥ 4 weeks prior to Day 1; Body weight ≥ 40 kg and < 160 kg.
Kizáró feltételek: Treatment with > 1 immunosuppressant therapy; Treatment with biological immunomodulators, such as tumor necrosis factor-alpha (TNF-α) inhibitors or antifibrotics or interleukin inhibitors; Patients with cutaneous or ocular sarcoidosis, which in the opinion of the Investigator, are at risk for exacerbation, necessitating OCS rescue or other systemic therapy; History of Addisonian symptoms that precluded previous OCS taper attempts; In the opinion of the investigator, clinically significant pulmonary hypertension; Patients with active cardiac, neuro, or renal sarcoidosis requiring organ-specific therapy in the past 2 years; History of anti-synthetase syndrome or Jo-1 positive at Screening; Patients with active tuberculosis or those currently undergoing treatment for tuberculosis; Likelihood of significant pulmonary fibrosis as shown by any 1 or more of the following: High resolution CT fibrosis > 20% within the last 12 months; FVC percent predicted (FVCPP) < 50% and KSQ-Lung score < 30; Is an active, heavy smoker of tobacco/nicotine-containing products.