Plaque Psoriasis PatientsPhase 3NCT06299982
An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
A Phase 3 study testing 608 Q2W and 608 Q4W in people with Plaque Psoriasis Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd..
Trial summary
The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants 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
- Plaque Psoriasis Patients
- What is being tested?
- 608 Q2W and 608 Q4W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 20 Mar 2025
- 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
- Age ≥18 years old, both male and female.
- Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).
Who cannot join
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
- Other inflammatory diseases.
- Active autoimmune diseases.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter,Randomized,Phase 3 Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
- Conditions
- Plaque Psoriasis Patients
- Being tested
- 608 Q2W, 608 Q4W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
608 Q2WDrug
608 160 mg at week 0 + 80 mg Q2W (5 cycles)
608 Q4WDrug
608 160 mg Q4W (3 cycles)
| Study group | Role | What they receive |
|---|---|---|
| 608 160 mg W0+80 mg Q2W | Experimental | Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks. Receives: Drug: 608 Q2W |
| 608 160 mg Q4W | Experimental | Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks. Receives: Drug: 608 Q4W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Measured: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Measured: At Week 12
Secondary outcomes (4)
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Measured: At Week 12
Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Measured: At Week 12
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)
Measured: At Week 12
Adverse events (AE)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 May 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion20 Mar 2025 (estimated)
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 Plaque Psoriasis PatientsStudies of the same condition, open and under way.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) 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
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299982
- Sponsor's protocol ID
- SSGJ-608-PsO-III-02
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cai L, Chen J, Wu L, Duan X, Zhang G, Li Y, Zhang L, Qin L, Zeng T, Wang X, Wang J, Huang K, Ren H, Liu L, Ding Y, Cui Y, Shan Y, Lu J, Tao X, Chen R, Tu Y, Yan M, Zhu X, Qiao N, Meng Z, Wang Y, Cheng F, Yuan Y, Zhu J, Hu X, Guo S, Xia X, Man X, Wu Z, Chen X, Chen G, He Y, Lv D, Feng Y, Deng D, Geng S, Guo Q, Feng W, Zhu X, Liu Y, Lin B, Xia R, Yu C, Fan J, Ji M, Lei T, Yang W, Yang M, Gao Y, Li W, Jiang M, Lou J, Liu Y, Zhou C, Zhang J. SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study. Front Immunol. 2026 Jun 9;17:1810418. doi: 10.3389/fimmu.2026.1810418. eCollection 2026.
PubMed 42344898
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Randomized,Phase 3 Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06299982
- Acronym / sponsor ID
- SSGJ-608-PsO-III-02
- Conditions
- Plaque Psoriasis Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 8 Mar 2024 (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 examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 608 160 mg W0+80 mg Q2W | Experimental | Drug: 608 Q2WParticipants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks. |
| 608 160 mg Q4W | Experimental | Drug: 608 Q4WParticipants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years old, both male and female.
- Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).
Key exclusion criteria (4 listed)
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) .
- Other inflammatory diseases.
- Active autoimmune diseases.
- Pregnant or lactating women.
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 |
|---|---|---|
| 608 Q2W608 160 mg at week 0 + 80 mg Q2W (5 cycles) | Drug | 608 160 mg W0+80 mg Q2W |
| 608 Q4W608 160 mg Q4W (3 cycles) | Drug | 608 160 mg Q4W |
Primary outcome
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At Week 12
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
Time frame: At Week 12
4 secondary outcomes
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Time frame: At Week 12
Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Time frame: At Week 12
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0)
Time frame: At Week 12
Adverse events (AE)
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Derived from this study: PubMed 42344898Cai L, Chen J, Wu L, Duan X, Zhang G, Li Y, Zhang L, Qin L, Zeng T, Wang X, Wang J, Huang K, Ren H, Liu L, Ding Y, Cui Y, Shan Y, Lu J, Tao X, Chen R, Tu Y, Yan M, Zhu X, Qiao N, Meng Z, Wang Y, Cheng F, Yuan Y, Zhu J, Hu X, Guo S, Xia X, Man X, Wu Z, Chen X, Chen G, He Y, Lv D, Feng Y, Deng D, Geng S, Guo Q, Feng W, Zhu X, Liu Y, Lin B, Xia R, Yu C, Fan J, Ji M, Lei T, Yang W, Yang M, Gao Y, Li W, Jiang M, Lou J, Liu Y, Zhou C, Zhang J. SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study. Front Immunol. 2026 Jun 9;17:1810418. doi: 10.3389/fimmu.2026.1810418. eCollection 2026.
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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 608 Q2W and 608 Q4W in people with Plaque Psoriasis Patients, run by Sunshine Guojian Pharmaceutical (Shanghai) 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 2 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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. 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 Qinghong Zhou (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (time frame: At 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 NCT06299982, 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 8 Mar 2024.