Clinical trial NCT02129777
Conditions: Plaque Psoriasis
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2016-02-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Namilumab 300 mg (2 separate injections of 150 mg), subcutaneous injection, on Day 1, followed by namilumab 150 mg subcutaneous injection, on Days 15, 43 and 71. arm 2: Namilumab 160 mg (2 separate injections of 80 mg), subcutaneous injection, on Day 1, followed by namilumab 80 mg subcutaneous injection, on Days 15, 43 and 71. arm 3: Namilumab 100 mg (2 separate injections of 50 mg), subcutaneous injection, on Day 1, followed by namilumab 50 mg subcutaneous injection, on Days 15, 43 and 71. arm 4: Namilumab 40 mg (2 separate injections of 20 mg), subcutaneous injection, on Day 1, followed by namilumab 20 mg subcutaneous injection, on Days 15, 43 and 71. arm 5: Placebo (2 separate injections), subcutaneous injection, on Day 1, followed by placebo, subcutaneous injection, on Days 15, 43 and 71. arm 6: Namilumab 80 mg subcutaneous injection, at Week 0 and every 4 weeks thereafter up to 52 weeks (active extension period) - if appropriate on the basis of treatment response. arm 7: Namilumab 150 mg, subcutaneous injection, from Week 8 and then every 4 weeks thereafter up to 52 weeks (active extension period) - if appropriate on the basis of treatment response.
Interventions: intervention 1: Namilumab intervention 2: Placebo
Intervention descriptions: intervention 1: Namilumab subcutaneous injection intervention 2: Placebo subcutaneous injection

Protocol documents: