- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05536726
A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
January 12, 2023 updated by: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety 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
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Study SSGJ-608-PsO-III-01 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the effect of 2 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 and the primary endpoint measured at 12 weeks, followed by a randomized, double-blind, 40-week maintenance dosing period.
During the maintenance dosing period, the study will evaluate the maintenance of response/remission, as well as relapse following treatment.
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qinghong Zhou, MD
- Phone Number: 18911301578
- Email: zhouqinghong@3sbio.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Recruiting
- Shanghai Huanshan Hospital Fudan University
-
Contact:
- Jinhua Xu, MD
- Phone Number: 13818978539
- Email: xjhhsyy@163.com
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Contact:
- Jing Zhang, MD
- Phone Number: 13816357098
- Email: zhangj_fudan@163.com
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Principal Investigator:
- Jinhua Xu
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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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be 18 Years to 75 Years, both male and female.
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Randomization.
- 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).
- Fertile female subjects and male subjects (and their female partners) must take effective contraceptive measures within at least 6 months from the screening period to the last medication. The subjects have no fertility, sperm donation and egg donation plans within at least 6 months from the screening period to the last medication.
Exclusion Criteria:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
- Drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Have previously received any drug that directly targets IL-17 or IL-17 receptor, or IL-12 / IL-23, or IL-23.
- Biological agents or their biological analogues were used before randomization, including but not limited to: Etanercept < 28 days; Infliximab, adalimumab or afacet <60 days; Golimumab <90 days; Or other biological agents < 5 half lives.
- 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: 608 160 mg W0+80 mg Q2W+80 mg Q4W
Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection during induction period (12 weeks).
During the maintenance period, participants will receive 80mg 608 once every four weeks (Q4W).
|
608 160 mg at week 0 + 80 mg Q2W ( 6 cycles) +80 mg Q4W during maintenance period
|
Experimental: 608 160 mg Q4W+160 mg Q8W
Participants will receive 160mg 608 once every four weeks (Q4W) by subcutaneous injection during induction period (12 weeks) followed by 160mg 608 once every eight weeks (Q8W) during maintenance period.
|
608 160 mg Q4W ( 3 cycles) +160 mg Q8W during maintenance period
|
Placebo Comparator: Placebo
Participants will receive Placebo by subcutaneous injection during induction period and then, will be re-randomized to either receive starting dose of 160mg 608 at week 12 followed by 80mg 608 once every four weeks (Q4W) or 160mg 608 once every eight weeks (Q8W) during maintenance period.
|
Participants will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Other Names:
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What is the study measuring?
Primary 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).
|
At Week 12
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Key Secondary: 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
|
Key Secondary: 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
|
Key Secondary: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)
Time Frame: At Week 12
|
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).
|
At Week 12
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In the IMP Group, Percentage of Participants Still Maintaining PASI 75, PASI 90 and sPGA 0/1 At Week 52 From Week 12 for Participants Who Achieved PASI 75, PASI 90 and sPGA 0/1
Time Frame: At Week 52
|
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 52
|
Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
Time Frame: At Week 12
|
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable).
Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
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At Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Qinghong Zhou, MD, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Principal Investigator: Jinhua Xu, MD, Shanghai Huanshan Hospital Fudan University-Dermatology
- Principal Investigator: Jing Zhang, MD, Shanghai Huanshan Hospital Fudan University
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 (Anticipated)
January 3, 2023
Primary Completion (Anticipated)
July 23, 2023
Study Completion (Anticipated)
June 23, 2024
Study Registration Dates
First Submitted
September 8, 2022
First Submitted That Met QC Criteria
September 8, 2022
First Posted (Actual)
September 13, 2022
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSGJ-608-PsO-III-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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