Back to resultsStudy of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1314 injection
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility Criteria
Inclusion Criteria:
- The subject voluntarily signs an informed consent form before any procedures related to the research start;
- Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
- At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
- There is active PsA before randomization;
- Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
Exclusion Criteria:
- Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
- Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
- Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
- A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Sites / Locations
- Huashan Hospital of the Shanghai FuDan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SHR-1314 injection
placebo
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects achieving ACR 20 improvement at week 12
Secondary Outcome Measures
The proportion of subjects who achieved ACR 50 improvement (week 12)
The proportion of subjects who achieved ACR 70 improvement (week 12)
Full Information
NCT ID
NCT05055934
First Posted
September 15, 2021
Last Updated
November 26, 2021
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05055934
Brief Title
Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
January 23, 2023 (Anticipated)
Study Completion Date
January 23, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1314 injection
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1314 injection
Intervention Description
SHR-1314 injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Proportion of subjects achieving ACR 20 improvement at week 12
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
The proportion of subjects who achieved ACR 50 improvement (week 12)
Time Frame
week 12
Title
The proportion of subjects who achieved ACR 70 improvement (week 12)
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject voluntarily signs an informed consent form before any procedures related to the research start;
Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
There is active PsA before randomization;
Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
Exclusion Criteria:
Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siai Sun
Phone
18036618062
Email
siai.sun@hengrui.com
Facility Information:
Facility Name
Huashan Hospital of the Shanghai FuDan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Deng
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
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