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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05604898
• Other study ID #: SSGJ -608- Psoriasis-II-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: August 2023

Study information

• Verified date: November 2022
• Source: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: August 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cmax	To assess the maximum plasma level of 608.	Week 0 to 16
Secondary	Tmax	To assess the time to peak 608 concentration.	Week 0 to 16
Secondary	AUC0-last	To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.	Week 0 to 16
Secondary	AUC0-tau	To assess the area under the concentration time-curves from time zero to the dosing interval tau.	Week 0 to 16
Secondary	Cmin	To assess the minimum plasma level of 608.	Week 0 to 48
Secondary	Rac_Cmax	Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac_Cmax = Cmax at steady state (ss) divided by Cmax at first dose.	week 0,12
Secondary	Rac_AUC0-tau	Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCtau) from time 0-tau(Week 12) divided by AUC from time 0-tau (Week 0)	week 0,12
Secondary	Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.	Serum ADA positivity is determined over course of the trial duration.	Week 0,4,8,12,16,24,48,64
Secondary	Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.	Serum ADA positivity is determined over course of the trial duration.	Week 0,8,20,44,64
Secondary	Percentage of Participants Achieving a =75% Improvement in Psoriasis Area and Severity Index (PASI 75)	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).	At Week 12
Secondary	Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement	The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a postbaseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.	At Week 12
Secondary	Percentage of Participants Achieving a =90% Improvement in Psoriasis Area and Severity Index (PASI 90)	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).	At Week 12
Secondary	Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)	The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs(0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).	At Week 12