Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis
Megadott ok: Sponsor decision
A legfontosabb adatok
- Hol
- Atlanta, Baltimore, Chapel Hill, Charleston, Chicago, Cleveland, Durham, Fairway, Irvine, Las Vegas, Manhasset, Memphis, New York, North Richland Hills, Phoenix, Pittsburgh, Santa Monica, Seattle, Tampa és Washington D.C. (Egyesült Államok)Mind a 20 helyszín megnézése
- Fázis
- 2/3. fázis
Helyszínek itt: Egyesült Államok
- Atlanta, GeorgiaHospital not named in the registryNo longer taking part
- Baltimore, MarylandHospital not named in the registryNo longer taking part
- Chapel Hill, North CarolinaHospital not named in the registryNo longer taking part
- Charleston, West VirginiaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cleveland, OhioHospital not named in the registryNo longer taking part
- Durham, North CarolinaHospital not named in the registryNo longer taking part
- Fairway, KansasHospital not named in the registryNo longer taking part
- Irvine, CaliforniaHospital not named in the registryNo longer taking part
- Las Vegas, NevadaHospital not named in the registryNo longer taking part
- Manhasset, New YorkHospital not named in the registryNo longer taking part
- Memphis, TennesseeHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- North Richland Hills, TexasHospital 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
- Santa Monica, CaliforniaHospital not named in the registryNo longer taking part
- Seattle, WashingtonHospital 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
A vizsgálat adatai
- Ki végzi
- Alexion Pharmaceuticals, Inc.
- Azonosító
- NCT04999020
- A regiszteradat frissítve
- 2025. július 9.
- Eredeti leírás
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).A teljes eredeti leírásKevesebb
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis
This is a Phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (DM).
Bevonási feltételek: 18 years of age or older at the time of signing the informed consent; Body weight ≥ 30 kilograms at the time of Screening; Male or female; Diagnosis: Meet 2017 American College of Rheumatology/European League Against Rheumatism classification criteria for definite or probable DM; Participants who have an inadequate response or are intolerant to 1 or more DM treatments, including systemic corticosteroids or immunosuppressive/immunomodulatory therapies (for example, azathioprine, methotrexate, rituximab, intravenous immunoglobulin), either in combination or as monotherapy; Vaccinated against Neisseria meningitidis within 3 years prior to initiating ravulizumab as per national and local guidelines. Participants must receive the vaccination at least 2 weeks before first study intervention. The sponsor recommends that national and local guidelines for prophylactic antibiotics should also be followed; Female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol.
Kizáró feltételek: Participants who have been diagnosed with cancer within the last 3 years need to have appropriate negative cancer screening as per local standard of care within 6 months before Screening (basal or squamous cell skin cancer or carcinoma in situ of the cervix needs to have been excised and without evidence of residual disease for at least 3 months before Screening); Evidence of active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors; Active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration; Presence of fever ≥ 38°Celsius (100.4°Fahrenheit) within 7 days prior to study drug administration on Day 1; As per investigator discretion, participants with significant muscle damage (for example, severe muscle atrophy, end stage muscle disease, MRI with severe atrophy or fibrofatty replacement); History of Neisseria meningitidis infection; Human immunodeficiency virus (HIV) infection (evidenced by HIV Type 1 or Type 2 antibody titer); History of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab; Participants with other forms of myositis; Pregnant, breastfeeding, or intending to conceive during the course of the study; Inability or unwillingness to adhere to the protocol requirements.