search
Back to results

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

Primary Purpose

Psoriasis

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
Placebo
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
Placebo
Sponsored by
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Huashan Hospital Fudan University
  • Shanghai Dermatology Hospital
  • The First Affiliated Hospital of Kunming Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1:608 40 mg

Part 1:608 80 mg

Part 1:608 160 mg

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

Part 2:608 160 mg Q2W+160 mg Q4W

Part 2:608 160 mg Q4W+160 mg Q8W

Part 2:Placebo

Arm 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.

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.

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.

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).

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.

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.

Participants will receive Placebo by subcutaneous injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cmax
To assess the maximum plasma level of 608.
Tmax
To assess the time to peak 608 concentration.
AUC0-last
To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.
AUC0-tau
To assess the area under the concentration time-curves from time zero to the dosing interval tau.
Cmin
To assess the minimum plasma level of 608.
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.
Rac_AUC0-tau
Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau(Week 12) divided by AUC from time 0-τau (Week 0)
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
Serum ADA positivity is determined over course of the trial duration.
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
Serum ADA positivity is determined over course of the trial duration.
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).
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.
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).
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).

Full Information

First Posted
October 31, 2022
Last Updated
November 7, 2022
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05604898
Brief Title
A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1:608 40 mg
Arm Type
Experimental
Arm 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.
Arm Title
Part 1:608 80 mg
Arm Type
Experimental
Arm 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.
Arm Title
Part 1:608 160 mg
Arm Type
Experimental
Arm 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.
Arm Title
Part 2:608 160 mg W0+80 mg Q2W+80 mg Q4W
Arm Type
Experimental
Arm 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).
Arm Title
Part 2:608 160 mg Q2W+160 mg Q4W
Arm Type
Experimental
Arm 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.
Arm Title
Part 2:608 160 mg Q4W+160 mg Q8W
Arm Type
Experimental
Arm 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.
Arm Title
Part 2:Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive Placebo by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
Other Intervention Name(s)
608
Intervention Description
608 will be administered subcutaneously.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Intervention Type
Drug
Intervention Name(s)
Recombinant Anti-IL-17A Humanized Monoclonal Antibody Injection
Other Intervention Name(s)
608
Intervention Description
608 will be provided at pre-specified time intervals.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Primary Outcome Measure Information:
Title
Incidence and severity of treatment emergent adverse event (TEAE).
Description
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.
Time Frame
Up to 64 Weeks
Secondary Outcome Measure Information:
Title
Cmax
Description
To assess the maximum plasma level of 608.
Time Frame
Week 0 to 16
Title
Tmax
Description
To assess the time to peak 608 concentration.
Time Frame
Week 0 to 16
Title
AUC0-last
Description
To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.
Time Frame
Week 0 to 16
Title
AUC0-tau
Description
To assess the area under the concentration time-curves from time zero to the dosing interval tau.
Time Frame
Week 0 to 16
Title
Cmin
Description
To assess the minimum plasma level of 608.
Time Frame
Week 0 to 48
Title
Rac_Cmax
Description
Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac_Cmax = Cmax at steady state (ss) divided by Cmax at first dose.
Time Frame
week 0,12
Title
Rac_AUC0-tau
Description
Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau(Week 12) divided by AUC from time 0-τau (Week 0)
Time Frame
week 0,12
Title
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
Description
Serum ADA positivity is determined over course of the trial duration.
Time Frame
Week 0,4,8,12,16,24,48,64
Title
Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
Description
Serum ADA positivity is determined over course of the trial duration.
Time Frame
Week 0,8,20,44,64
Title
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Description
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).
Time Frame
At Week 12
Title
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Description
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.
Time Frame
At Week 12
Title
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Description
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).
Time Frame
At Week 12
Title
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Description
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).
Time Frame
At Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu, MD
Organizational Affiliation
Shanghai Huanshan Hospital Fudan University-Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs