Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding and Proof of Concept Study, to Assess the Efficacy, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Namilumab/MT203 At 4 Different Subcutaneous Doses in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Status Completed

Clinical Trial Summary

The purpose of this study is to establish proof of efficacy of namilumab in moderate to severe plaque psoriasis, measured as Psoriasis Area and Severity Index (PASI)75 response rate at week 12.

Clinical Trial Description

The drug being tested in this study is called namilumab. Namilumab is being tested to prove its effectiveness in treating moderate to severe chronic plaque psoriasis. This study will look at improvement of plaque psoriasis in people who take namilumab.

The study will enroll approximately 120 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the five treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

• Namilumab subcutaneous injection 300 mg Day 1, 150 mg Days 15, 43 and 71

• Namilumab subcutaneous injection 160 mg Day 1, 80 mg Days 15, 43 and 71

• Namilumab subcutaneous injection 100 mg Day 1, 50 mg Days 15, 43 and 71

• Namilumab subcutaneous injection 40 mg Day 1, 20 mg Days 15, 43 and 71

• Placebo (dummy inactive subcutaneous injection) - this is a liquid solution that looks like the study drug but has no active ingredient Days 1, 15, 43 and 71.

This study will consist of two parts. Eligible participants will receive 10 weeks of treatment with double-blinded study medication in a dose-finding and proof-of-concept investigation, followed by an extended treatment period (intended to be 52 weeks) with open-label study medication. At Week 12 participants will be assessed for primary endpoint response, which will determine the course of their progression through the open-label treatment period. Participants who show ≥ 75% reduction of Baseline (Day 1) Psoriasis Area and Symptoms Index (PASI) at Week 12, "Responders", will begin a washout interval (for a maximum of 24 weeks) with no use of study medication: this interval will continue until a partial loss of response is recorded (defined as ≥ 25% increase in PASI score over that recorded at Week 12) in assessments conducted on a 2-weekly basis - thereby prompting the start of dosing with open-label (OL) study medication (Week 0 OL through Week 52 OL). In contrast, participants who do not show ≥ 75% reduction of Baseline PASI at Week 12, "Partial/Non-Responders", will begin the open-label extension period 4 weeks after the final dose of blinded study medication.

Participants will then be followed-up through an 18-week post-treatment assessment period. During the open-label extension period participants will begin dosing with 80 mg namilumab; however, if an inadequate treatment response is recorded, then dose escalation to 150 mg namilumab will be implemented. Open-label study medication will be administered subcutaneously at 4 week intervals.

This multi-centre trial will be conducted in North America and Europe. The overall time to participate in the double-blind period of this study is up to 34 weeks The overall time to participate in the open-label period is 70 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

• NCT number: NCT02129777
• Study type: Interventional
• Source: Takeda
• Status: Completed
• Phase: Phase 2
• Start date: June 2014
• Completion date: February 2016