Psoriatic ArthritisPhase 2NCT05055934
Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis
A Phase 2 study testing SHR-1314 injection in people with Psoriatic Arthritis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- SHR-1314 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2021to 5 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital of the Shanghai FuDan University
Shanghai, Shanghai Municipality, 200433
About this study
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
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.
- Conditions
- Psoriatic Arthritis
- Being tested
- SHR-1314 injection, placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314 injectionDrug
SHR-1314 injection
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-1314 injection | Experimental | Not described Receives: Drug: SHR-1314 injection |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving ACR 20 improvement at week 12
Measured: at week 12
Secondary outcomes (2)
The proportion of subjects who achieved ACR 50 improvement (week 12)
Measured: week 12
The proportion of subjects who achieved ACR 70 improvement (week 12)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start22 Oct 2021
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055934
- Sponsor's protocol ID
- SHR-1314-204
- Status last verified
- Sep 2021
- First submitted
- 15 Sep 2021
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xue Y, Sun L, Zhang N, Chen H, Shi X, Liu S, Chen L, Ma X, Wei H, Jiang Z, Li X, Fan H, Li H, Li J, Wu R, Shi G, Zhu J, Kong X, Lu Y, Liu P, Zheng Q, Bai X, Zhang S, Wan W, Zou H. Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study. Rheumatology (Oxford). 2026 Feb 4;65(2):keag060. doi: 10.1093/rheumatology/keag060.
PubMed 41632483
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05055934
- Acronym / sponsor ID
- SHR-1314-204
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1314 injection | Experimental | Drug: SHR-1314 injection |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-1314 injectionSHR-1314 injection | Drug | SHR-1314 injection |
| placeboplacebo | Drug | placebo |
Primary outcome
Proportion of subjects achieving ACR 20 improvement at week 12
Time frame: at week 12
2 secondary outcomes
The proportion of subjects who achieved ACR 50 improvement (week 12)
Time frame: week 12
The proportion of subjects who achieved ACR 70 improvement (week 12)
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 41632483Xue Y, Sun L, Zhang N, Chen H, Shi X, Liu S, Chen L, Ma X, Wei H, Jiang Z, Li X, Fan H, Li H, Li J, Wu R, Shi G, Zhu J, Kong X, Lu Y, Liu P, Zheng Q, Bai X, Zhang S, Wan W, Zou H. Vunakizumab in patients with active psoriatic arthritis: a multicentre, randomized, double-blind, placebo-controlled, phase 2 study. Rheumatology (Oxford). 2026 Feb 4;65(2):keag060. doi: 10.1093/rheumatology/keag060.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1314 injection in people with Psoriatic Arthritis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving ACR 20 improvement at week 12 (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.