A Study to Evaluate Further Therapeutic Strategies With Guselkumab in Participants With Moderate-to-Severe Plaque-Type Psoriasis

Summary

The purpose of this study is to demonstrate that Super-Responders (SRe; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a Psoriasis Area and Severity Index score (PASI) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).

Timeline

Start

2019-02-08

Primary completion

2022-03-07

Completion

2025-01-07

Publications

• Eyerich K, Asadullah K, Pinter A, Weisenseel P, Reich K, Paul C, Sabat R, Wolk K, Eyerich S, Lauffer F, Angsana J, Taut FJH, Kohler K, Chen Y, Sendecki J, Leung MWL, Wegner S, Personke Y, Gomez M, Kruger N, Tabori S, Schakel K. Noninferiority of 16-Week vs 8-Week Guselkumab Dosing in Super Responders for Maintaining Control of Psoriasis: The GUIDE Randomized Clinical Trial. JAMA Dermatol. 2024 Sep 1;160(9):953-963. doi: 10.1001/jamadermatol.2024.2463.
• Eyerich K, Weisenseel P, Pinter A, Schakel K, Asadullah K, Wegner S, Munoz-Elias EJ, Bartz H, Taut FJH, Reich K. IL-23 blockade with guselkumab potentially modifies psoriasis pathogenesis: rationale and study protocol of a phase 3b, randomised, double-blind, multicentre study in participants with moderate-to-severe plaque-type psoriasis (GUIDE). BMJ Open. 2021 Sep 13;11(9):e049822. doi: 10.1136/bmjopen-2021-049822.

Drugs

Indications