Efficacy and Safety of Namilumab (MT203) for Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      The drug tested in this study is called namilumab. Namilumab was tested to prove its
      effectiveness in treating moderate to severe chronic plaque psoriasis. This study looked at
      improvement of plaque psoriasis in participants who take namilumab.

      The study enrolled 122 participants. Participants were randomly assigned (by chance, like
      flipping a coin) to one of five treatment groups that were undisclosed to the patient and
      study doctor during the study (unless there was 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 consisted of two parts. Eligible participants received 10 weeks of treatment with
      double-blinded study medication, followed by an extended treatment period (active extension
      period, intended to be 52 weeks) with open-label study medication. At Week 12, participants
      were assessed for primary endpoint response, which determined the course of their progression
      through the open-label treatment period. Participants who showed >=75% reduction of Baseline
      (Day 1) PASI at Week 12, "Responders", began a washout interval (for a maximum of 24 weeks)
      with no use of study medication: this interval continued until a partial (25%) loss of Week
      12 treatment response is recorded in assessments conducted on a 2-weekly basis - thereby
      prompting the start of dosing with open-label (OL) study medication (Day 0 OL through Week 52
      OL). In contrast, participants who did not show >=75% reduction of Baseline PASI score at
      Week 12, "Partial/Non-Responders", began the open-label extension period 4 weeks after the
      final dose of blinded study medication.

      Participants were then followed-up through an 18-week post-treatment assessment period during
      which no medication was given. During the open-label extension period participants began
      dosing with 80 mg namilumab; however, if an inadequate treatment response was recorded, then
      dose escalation to 150 mg namilumab was implemented.
    

Intervention name(s): Namilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Namilumab subcutaneous injection; Placebo subcutaneous injection
Other intervention name(s): MT203
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy