NCT05604898

A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 2，Multicenter, Randomized, Double-blind, Placebo-controlled，Multiple-dose Escalation and Dose Finding Study to Evaluate the Safety，PK and Efficacy of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.

Detailed description

Study SSGJ-608-PsO-II-01 is a phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple-dose escalation and dose finding study to identify the doses of treatments ，and to further evaluate the effect of different dose regimens of recombinant anti-IL-17A humanized monoclonal antibody versus placebo in Chinese participants with moderate-to-severe plaque psoriasis during an induction dosing period with dosing for 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period. Phase Ib One of three dose levels of copanlisib is assigned at registration according to the dose escalation scheme. Phase II The copanlisib dose for the Phase II part of the trial will be based on the MTD established in the Phase Ib part of the study.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection	608 will be administered subcutaneously.
OTHER	Placebo	Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
DRUG	Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection	608 will be provided at pre-specified time intervals.
OTHER	Placebo	Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-05-01
• Completion: 2023-08-01
• First posted: 2022-11-03
• Last updated: 2022-11-08

Locations

3 sites across 1 country: China