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

Sunshine Guojian Pharmaceutical

Status and phase

Active, not recruiting

Phase 2

Conditions

Psoriasis

Treatments

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05604898

SSGJ -608- Psoriasis-II-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

139 participants in 7 patient groups, including a placebo group

Part 1：608 40 mg

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Other: Placebo

Part 1：608 80 mg

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Other: Placebo

Part 1：608 160 mg

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Other: Placebo

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

Experimental group

Description:

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).

Treatment:

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Other: Placebo

Part 2：608 160 mg Q2W+160 mg Q4W

Experimental group

Description:

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.

Treatment:

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Part 2：608 160 mg Q4W+160 mg Q8W

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection

Other: Placebo

Part 2：Placebo

Placebo Comparator group

Description:

Participants will receive Placebo by subcutaneous injection.

Treatment:

Other: Placebo