Moderate to Severe Plaque PsoriasisPhase 2NCT06875934
A Trial Comparing SHR-1139 Injection With Placebo in Patients With Moderate-to-severe Plaque Psoriasis
A Phase 2 study testing SHR-1139 Injection in people with Moderate to Severe Plaque Psoriasis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection 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-1139 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2025to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
- Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
- A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner).
- Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.
Who cannot join
- There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
- A history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study.
- Had an opportunistic infection within 6 months prior to screening.
- Allergic to the ingredients or excipients of the study drug.
- The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Dermatology Hospital
Shanghai, Shanghai Municipality, 200435
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate-to-severe Plaque Psoriasis
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- SHR-1139 Injection, SHR-1139 Injection Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139 InjectionDrug
SHR-1139 injection.
SHR-1139 Injection PlaceboDrug
SHR-1139 injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1139 injection group | Experimental | Not described Receives: Drug: SHR-1139 Injection |
| SHR-1139 injection placebo group | Placebo comparator | Not described Receives: Drug: SHR-1139 Injection Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Measured: At week 16.
Secondary outcomes (4)
Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Measured: At week 16.
Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Measured: At week 16.
Adverse events (AEs)
Measured: Up to week 64.
Serum concentration of SHR-1139.
Measured: Up to week 64.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start28 Mar 2025
- Primary completionNov 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875934
- Sponsor's protocol ID
- SHR-1139-201
- Status last verified
- Jul 2025
- First submitted
- 9 Mar 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of SHR-1139 Injection in Patients With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06875934
- Acronym / sponsor ID
- SHR-1139-201
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Mar 2025 (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 objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 injection in patients with moderate to severe plaque psoriasis.
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-1139 injection group | Experimental | Drug: SHR-1139 Injection |
| SHR-1139 injection placebo group | Placebo comparator | Drug: SHR-1139 Injection Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age ≥ 18 years old at the time of signing the informed consent form (ICF).
- Subjects voluntarily sign informed consent form (ICF) prior to the commencement of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical study protocol.
- A fertile female subject or a male subject whose partner is a fertile woman who has not had a child, has a sperm/egg donation plan for 72 weeks from the date of signing the informed consent form to the last dose, and is voluntarily using highly effective contraception (including the partner).
- Female subjects must have negative pregnancy test results during the screening period and before randomized administration, and must be non-lactating.
Key exclusion criteria (5 listed)
- There are other skin problems that researchers believe can interfere with the evaluation of psoriasis.
- A history of moderate to severe congestive heart failure, cardiovascular and cerebrovascular events or severe bleeding events occurred in the 3 months before screening, and the investigator considered this subject to be unfit for clinical study.
- Had an opportunistic infection within 6 months prior to screening.
- Allergic to the ingredients or excipients of the study drug.
- The investigator determined that there were conditions that affected the safety and efficacy evaluation of the study drug.
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-1139 InjectionSHR-1139 injection. | Drug | SHR-1139 injection group |
| SHR-1139 Injection PlaceboSHR-1139 injection placebo. | Drug | SHR-1139 injection placebo group |
Primary outcome
Proportion of subjects with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
4 secondary outcomes
Proportion of subjects with at least 75% improvement (PASI 75) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
Proportion of subjects with at least 100% improvement (PASI 100) in their PASI (Psoriasis Area and Severity Index) score from the baseline.
Time frame: At week 16.
Adverse events (AEs)
Time frame: Up to week 64.
Serum concentration of SHR-1139.
Time frame: Up to week 64.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- 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-1139 Injection in people with Moderate to Severe Plaque Psoriasis, run by Guangdong Hengrui Pharmaceutical 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 with at least 90% improvement (PASI 90) in their PASI (Psoriasis Area and Severity Index) score from the baseline. (time frame: At week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2025.