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Clinical trial

Phase IIa Proof-of-Concept Study, With Dose-Titration Based on Treat-to-Target Strategy, to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Injection of Folate-based Liposomes Encapsulating Methotrexate (FBL-MTX) in Disease-modifying Antirheumatic Drugs (DMARD)-naïve Patients With Moderate-to-Severe Active Rheumatoid Arthritis and in Patients With an Inadequate Response or Intolerance to Oral MTX.

NCT06565273 is registered in ClinicalTrials.gov with SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd as lead sponsor.

NCT NCT06565273
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Registry record

As filed in ClinicalTrials.gov.

Title
Phase IIa Proof-of-Concept Study, With Dose-Titration Based on Treat-to-Target Strategy, to Investigate the Efficacy, Safety, and Tolerability of Subcutaneous Injection of Folate-based Liposomes Encapsulating Methotrexate (FBL-MTX) in Disease-modifying Antirheumatic Drugs (DMARD)-naïve Patients With Moderate-to-Severe Active Rheumatoid Arthritis and in Patients With an Inadequate Response or Intolerance to Oral MTX.
Lead sponsor
SOLFARCOS - Pharmaceutical and Cosmetic Solutions Ltd
Phase
Phase 2
Overall status
Completed
Start date
July 24, 2024
Completion date
July 20, 2026
Enrollment
40 (actual)
Sites
8

Conditions

As the registry lists them; a condition with its own page is linked.

rheumatoid arthritis