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

NCT ID: NCT05604898

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1：608 40 mg

Randomized in a 6:2 ratio to 608 40mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 40mg or placebo 4-weekly.

Group Type: EXPERIMENTAL

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be administered subcutaneously.

Placebo

Intervention Type: OTHER

Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.

Part 1：608 80 mg

Randomized in a 10:2 ratio to 608 80mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 80mg or placebo 4-weekly.

Group Type: EXPERIMENTAL

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be administered subcutaneously.

Placebo

Intervention Type: OTHER

Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.

Part 1：608 160 mg

Randomized in a 10:2 ratio to 608 160mg or placebo 2-weekly by subcutaneous injection during induction period. During the maintenance period, participants will receive 608 160mg or placebo 4-weekly.

Group Type: EXPERIMENTAL

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be administered subcutaneously.

Placebo

Intervention Type: OTHER

Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.

Part 2：608 160 mg W0+80 mg Q2W+80 mg Q4W

Participants will receive starting dose of 160 mg 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period. During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be provided at pre-specified time intervals.

Part 2：608 160 mg Q2W+160 mg Q4W

Participants will receive 160mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period followed by 160mg 608 once every four weeks (Q4W) during maintenance period.

Group Type: EXPERIMENTAL

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be provided at pre-specified time intervals.

Part 2：608 160 mg Q4W+160 mg Q8W

Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

608 will be provided at pre-specified time intervals.

Part 2：Placebo

Participants will receive Placebo by subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Interventions

Placebo

Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.

Intervention Type: OTHER

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

608 will be administered subcutaneously.

Intervention Type: DRUG

Placebo

Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.

Intervention Type: OTHER

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

608 will be provided at pre-specified time intervals.

Intervention Type: DRUG

Other Intervention Names

608; PBO; 608; PBO

Eligibility Criteria

Inclusion Criteria

• Must be 18 Years to 65 Years, both male and female.
• BMI ≥18 kg/m^2 and ≤32 kg/m^2 ，and male weight ≥50 kg, female weight ≥45 kg during the screening.
• Chronic plaque psoriasis (PSO) for at least 6 months prior to the randomizationas as determined by the investigator..
• Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Static Physician Global Assessment (sPGA) score >=3.
• According to the judgment of the investigator, the subject needs to receive systemic treatment and / or phototherapy (including subjects who have used local treatment, and / or phototherapy, and / or poor control of previous systemic treatment).
• Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.

Exclusion Criteria

• History of pustular or erythrodermic psoriasis other than plaque psoriasis at screening or baseline.
• History of drug-induced psoriasis.
• Ongoing use of prohibited treatments.
• Have previously received any drug that directly targets IL-17.
• Have concurrent or recent use of any biologic agent within washout periods or <5 half-lives prior to randomization.
• Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), syphilis and/ or active tuberculosis.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhua Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Huanshan Hospital Fudan University-Dermatology

Locations

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Countries

China

Other Identifiers

SSGJ -608- Psoriasis-II-01

Identifier Type: -

Identifier Source: org_study_id