Moderate-to-Severe Plaque PsoriasisPhase 3NCT04839016
Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis
A Phase 3 study testing SHR-1314 in people with Moderate-to-Severe Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-Severe Plaque Psoriasis
- What is being tested?
- SHR-1314
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2021to 30 Aug 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 18 years of age at time of screening.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
- Moderate to severe psoriasis as defined at Baseline/ randomization by:
- PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
- Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
- Body Mass Index (BMI) is 18 kg/m2 or above at screening
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
- Drug-induced psoriasis.
- Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
- Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
- History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
- At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
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- History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
- Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization.
- History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide.
- All subjects will be tested for tuberculosis status using IGRA and X-ray test.
- Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
- Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Being tested
- SHR-1314, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
SHR-1314
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1314 |
| Treatment group B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12
Measured: Week 12
sPGA of 0 or 1 response at Week 12
Measured: Week 12
Secondary outcomes (3)
Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12；
Measured: Week 12；
Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12
Measured: Week 12
sPGA of 0 response at 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 posted9 Apr 2021
- Study start25 Apr 2021 (estimated)
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderate-to-Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839016
- Sponsor's protocol ID
- SHR-1314-301
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wei Z, Xu L, Wang A. Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis. Front Immunol. 2026 Oct 14;17:1894231. doi: 10.3389/fimmu.2026.1894231. eCollection 2026.
PubMed 42952621Yan K, Li F, Bi X, Han L, Zhang Z, Chen R, Li Y, Zhang L, Wang X, Li L, Lu J, Xu A, Yang S, Lu Y, Sun J, Li Z, Zhu X, Jiang M, Zhang S, Wang W, Li Y, Meng Z, Li H, Mou K, Han X, Li S, Chen A, Li X, Liu D, Zhang C, Ji C, Wang Y, Cheng H, Cui X, Yao X, Bai X, Dong G, Xu J. Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26.
PubMed 39332633
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT04839016
- Acronym / sponsor ID
- SHR-1314-301
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2021 (estimated)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 9 Apr 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.
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1314 |
| Treatment group B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men or women at least 18 years of age at time of screening.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
- Moderate to severe psoriasis as defined at Baseline/ randomization by:
- PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
- Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
Key exclusion criteria (12 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
- Drug-induced psoriasis.
- Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
- Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
- History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
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-1314SHR-1314 | Drug | Treatment group A |
| PlaceboPlacebo | Drug | Treatment group B |
Primary outcome
Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12
Time frame: Week 12
sPGA of 0 or 1 response at Week 12
Time frame: Week 12
3 secondary outcomes
Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12；
Time frame: Week 12；
Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12
Time frame: Week 12
sPGA of 0 response at Week 12
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Derived from this study: PubMed 42952621Wei Z, Xu L, Wang A. Selected adverse events during the 12-week induction period of a phase III trial of vunakizumab: an exploratory post-hoc analysis. Front Immunol. 2026 Oct 14;17:1894231. doi: 10.3389/fimmu.2026.1894231. eCollection 2026.
- Derived from this study: PubMed 39332633Yan K, Li F, Bi X, Han L, Zhang Z, Chen R, Li Y, Zhang L, Wang X, Li L, Lu J, Xu A, Yang S, Lu Y, Sun J, Li Z, Zhu X, Jiang M, Zhang S, Wang W, Li Y, Meng Z, Li H, Mou K, Han X, Li S, Chen A, Li X, Liu D, Zhang C, Ji C, Wang Y, Cheng H, Cui X, Yao X, Bai X, Dong G, Xu J. Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR-1314 in people with Moderate-to-Severe Plaque Psoriasis, run by Jiangsu HengRui Medicine Co., Ltd..
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Shen (0518-82342973, Shenyang@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT04839016, which also lists 2 linked publications.
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 9 Apr 2021.