NCT02270632

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.

Detailed description

The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX. Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms: * Arm 1: placebo + MTX * Arm 2: F8IL10 30 µg/kg + MTX * Arm 3: F8IL10 160 µg/kg + MTX F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	F8IL10	F8IL10 will be administered once a week for 8 weeks (or until withdrawn from the study).
DRUG	MTX	All patients enrolled in the study will receive as concomitant therapy MTX at stable dose (10-25 mg/week), and the corresponding fixed dose of folic acid.
DRUG	Placebo	Placebo will be administered once a week for 8 weeks (or until withdrawn from the study).

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-04-01
• Completion: 2023-06-08
• First posted: 2014-10-21
• Last updated: 2023-06-12

Locations

8 sites across 3 countries: Germany, Italy, Switzerland