- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05604898
A Phase 2 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
November 7, 2022 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
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
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.
Study Overview
Status
Active, not recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200040
- Huashan Hospital Fudan University
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Shanghai, Shanghai, China, 200050
- Shanghai Dermatology Hospital
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Yunnan
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Kunming, Yunnan, China, 650000
- The First Affiliated Hospital of Kunming Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
608 will be administered subcutaneously.
Other Names:
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
Experimental: 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.
|
608 will be administered subcutaneously.
Other Names:
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
Experimental: 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.
|
608 will be administered subcutaneously.
Other Names:
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
Experimental: 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).
|
608 will be administered subcutaneously.
Other Names:
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
Experimental: 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.
|
608 will be administered subcutaneously.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
|
Experimental: 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.
|
608 will be administered subcutaneously.
Other Names:
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
608 will be provided at pre-specified time intervals.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
Placebo Comparator: Part 2:Placebo
Participants will receive Placebo by subcutaneous injection.
|
Participants will receive Placebo to maintain the blinding of the Investigational Medicinal Products.
Other Names:
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence and severity of treatment emergent adverse event (TEAE).
Time Frame: Up to 64 Weeks
|
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.
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Up to 64 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time Frame: At Week 12
|
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).
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At Week 12
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Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Time Frame: At Week 12
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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.
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At Week 12
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Cmax
Time Frame: Week 0 to 16
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To assess the maximum plasma level of 608.
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Week 0 to 16
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Tmax
Time Frame: Week 0 to 16
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To assess the time to peak 608 concentration.
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Week 0 to 16
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AUC0-last
Time Frame: Week 0 to 16
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To assess the area under the concentration time-curves from time zero to the time of the last quantifiable concentration after dosing.
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Week 0 to 16
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AUC0-tau
Time Frame: Week 0 to 16
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To assess the area under the concentration time-curves from time zero to the dosing interval tau.
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Week 0 to 16
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Cmin
Time Frame: Week 0 to 48
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To assess the minimum plasma level of 608.
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Week 0 to 48
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Rac_Cmax
Time Frame: week 0,12
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Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac_Cmax = Cmax at steady state (ss) divided by Cmax at first dose.
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week 0,12
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Rac_AUC0-tau
Time Frame: week 0,12
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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)
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week 0,12
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Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 1.
Time Frame: Week 0,4,8,12,16,24,48,64
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Serum ADA positivity is determined over course of the trial duration.
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Week 0,4,8,12,16,24,48,64
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Number of Participants Positive for Anti-Drug Antibody (ADA) in Part 2.
Time Frame: Week 0,8,20,44,64
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Serum ADA positivity is determined over course of the trial duration.
|
Week 0,8,20,44,64
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Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Time Frame: At Week 12
|
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
|
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time Frame: At Week 12
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jinhua Xu, MD, Shanghai Huanshan Hospital Fudan University-Dermatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
October 31, 2022
First Submitted That Met QC Criteria
October 31, 2022
First Posted (Actual)
November 3, 2022
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSGJ -608- Psoriasis-II-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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