A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
Brief Summary:
This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults
Detailed Description:
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults
Estimated Study Start Date: October 30, 2019
Estimated Primary Completion Date: March 30, 2021
Estimated Study Completion Date: June 15, 2021
Arms:
- Active Comparator: Treatment group A
- Active Comparator: Treatment group B
- Active Comparator: Treatment group C
- Placebo Comparator: Placebo group
Category | Value |
---|---|
Date last updated at source | 2019-10-09 |
Study type(s) | Interventional |
Expected enrolment | 120 |
Study start date | 2019-10-30 |
Estimated primary completion date | 2019-03-30 |