Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565273
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Study to Investigate the Efficacy Safety and Tolerability of FBL-MTX in Patients With Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of FBL-MTX administered by subcutaneous route in Rheumatoid Arthritis patients
Participants will be screened within 28 days prior to treatment period to confirm that they meet the selection criteria for the study
Treatment period The treatment period will consist of eight sequential study visits separated by a 2-week interval
DMARD-naïve Patients Patients will be administered an initial dose of FBL-MTX of 1 mg by SC route Subsequent doses will be titrated according to clinical response at intervals of 4 weeks for 12 weeks Maximum dosage will be 25 mg every 2 weeks
Patients with an Inadequate Response or Intolerance to Oral MTX Patients will be administered an initial dose of FBL-MTX 25 mg by SC route Subsequent doses will be titrated according to clinical response at intervals of 4 weeks for 12 weeks Maximum dosage will be 25 mg every two weeks
Participants will be screened within 28 days prior to treatment period to confirm that they meet the selection criteria for the study
Treatment period The treatment period will consist of eight sequential study visits separated by a 2-week interval
DMARD-naïve Patients Patients will be administered an initial dose of FBL-MTX of 1 mg by SC route Subsequent doses will be titrated according to clinical response at intervals of 4 weeks for 12 weeks Maximum dosage will be 25 mg every 2 weeks
Patients with an Inadequate Response or Intolerance to Oral MTX Patients will be administered an initial dose of FBL-MTX 25 mg by SC route Subsequent doses will be titrated according to clinical response at intervals of 4 weeks for 12 weeks Maximum dosage will be 25 mg every two weeks
Detailed Description:
The Sponsor is developing folate-based liposomes encapsulating methotrexate FBL-MTX as a putative therapy for RA by intravenous IV or subcutaneous SC administration
Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy
This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA and collection data on its safety and tolerability
Considering the presented non-clinical and clinical data for FBL-MTX and that SC administration is the most adequate route for patient self-administration the Sponsor intends to proceed the clinical development of FBL-MTX with the objective of providing a more patient-friendly product with at least the same efficacy
This proof-of-concept study intends to demonstrate the plausibility of FBL-MTX SC administration in patients through the exploratory evaluation of SC FBL-MTX efficacy in patients with moderate-to-severe active RA and collection data on its safety and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None