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Monoclonal Antibodies

80mg SHR-1314-Part A for Plaque Psoriasis

Phase 1 & 2
Waitlist Available
Research Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline through 24 weeks (part a) or 36 weeks (part b)
Awards & highlights

Study Summary

This is a multi-regional, randomized, double-blind, placebo-controlled, clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SHR-1314 in adults with moderate-to-severe plaque psoriasis.

Eligible Conditions
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline through 24 weeks (part a) or 36 weeks (part b)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 24 weeks (part a) or 36 weeks (part b) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Significant Events (Part A)
Percentage of Participants With Anti-SHR-1314 Antibodies (Part A)
Percentage of subjects who achieve Psoriasis Area Severity Index (PASI) score 75 (Part B)
+1 more
Secondary outcome measures
Change from baseline in Body Surface Area (BSA)
Change of dermatology life quality index (DLQI) score
Physician's Global Assessment (PGA) of 0 or 1 achievement
+1 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: SHR-1314 Placebo (Part B)Experimental Treatment1 Intervention
SHR-1314 Placebo, subcutaneously
Group II: 80mg SHR-1314-Part AExperimental Treatment2 Interventions
SHR-1314 80mg, subcutaneously
Group III: 80mg SHR-1314 (Part B)Experimental Treatment1 Intervention
SHR-1314 80mg, subcutaneously
Group IV: 40mg SHR-1314 (Part B)Experimental Treatment1 Intervention
SHR-1314 40mg, subcutaneously
Group V: 240mg SHR-1314-Part AExperimental Treatment2 Interventions
SHR-1314 240mg, subcutaneously
Group VI: 240mg SHR-1314 (Part B)Experimental Treatment1 Intervention
SHR-1314 240mg, subcutaneously
Group VII: 160mg SHR-1314-Part AExperimental Treatment2 Interventions
SHR-1314 160mg, subcutaneously
Group VIII: 160mg SHR-1314 (Part B)Experimental Treatment1 Intervention
SHR-1314 160mg, subcutaneously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vunakizumab
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
626 Previous Clinical Trials
94,691 Total Patients Enrolled
Jianwen Chen, MD. Ph.D.Study ChairJiangsu HengRui Medicine Co., Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis
2017. "Multi-Dose Study of SHR-1314 in Subjects With Moderate-to-severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03463187.
~29 spots leftby Apr 2025
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