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

NCT05604898 | Unknown Phase 2

• 1 other identifier: SSGJ -608- Psoriasis-II-01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 3

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent adverse event (TEAE).

  The incidence and severity of treatment emergent adverse event (TEAE), including adverse events (AEs)，serious adverse event (SAE) and AEs associated with the use of the drug, as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc.

  Up to 64 Weeks

Secondary Outcomes (13)

• Cmax

  Week 0 to 16

• Tmax

  Week 0 to 16

• AUC0-last

  Week 0 to 16

• AUC0-tau

  Week 0 to 16

• Cmin

  Week 0 to 48

Study Arms (7)

Part 1：608 40 mg

EXPERIMENTAL

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.

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

Part 1：608 80 mg

EXPERIMENTAL

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.

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

Part 1：608 160 mg

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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).

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

Part 2：608 160 mg Q2W+160 mg Q4W

EXPERIMENTAL

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.

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

Part 2：608 160 mg Q4W+160 mg Q8W

EXPERIMENTAL

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.

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

Part 2：Placebo

PLACEBO COMPARATOR

Participants will receive Placebo by subcutaneous injection.

Other: Placebo

Interventions

Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection DRUG

608 will be administered subcutaneously.

Also known as: 608

Part 1：608 160 mg; Part 1：608 40 mg; Part 1：608 80 mg

Placebo OTHER

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

Also known as: PBO

Part 1：608 160 mg; Part 1：608 40 mg; Part 1：608 80 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (3)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Dermatology Hospital

Shanghai, Shanghai Municipality, 200050, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jinhua Xu, MD

  Shanghai Huanshan Hospital Fudan University-Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 3, 2022
• Study Start: April 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)