Plaque PsoriasisPhase 3NCT06945107
A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
A Phase 3 study testing Picankibart, Secukinumab and Ixekizumab in people with Plaque Psoriasis, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
Trial summary
This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Picankibart, Secukinumab and Ixekizumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2025to 19 Jan 2027
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged ≥18 years and ≤75 years.
- Diagnosed with plaque psoriasis for ≥6 months, with or without psoriatic arthritis.
- Regular use of secukinumab or ixekizumab according to the label information for at least 16 weeks prior to baseline (actual dose received ≥80% of the standard dose per instructions during the 16 weeks before baseline), with sufficient documented rationale for medication use.
- At both screening and baseline, meet the criteria of sPGA (Static Physician's Global Assessment) ≥2 and body surface area (BSA) involvement ≥3%, along with the investigator's assessment of inadequate response to the original IL-17 monoclonal antibody therapy, warranting a switch to biologic treatment.
- Full understanding of the trial objectives, basic knowledge of the pharmacological effects and potential adverse reactions of the investigational product, and voluntary provision of written informed consent in accordance with the principles of the Helsinki Declaration.
Who cannot join
- Diagnosed with guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis during screening or at baseline;
- Previous diagnosis of drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel inhibitors, etc.);
- Prior use of picankibart or IL-23 inhibitors;
- Received two biological agents for psoriasis treatment within 16 weeks prior to screening;
- Received topical treatments that may affect psoriasis evaluation within 2 weeks before the first administration of the investigational product (including but not limited to glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, keratoplastics, and combination therapies);
- Received conventional systemic medications that may affect psoriasis evaluation within 4 weeks before the first administration of the investigational product (including but not limited to methotrexate, cyclosporine, retinoids, azathioprine, leflunomide, mycophenolate mofetil, sulfasalazine, glucocorticoids, apremilast, JAK inhibitors such as tofacitinib/baricitinib/upadacitinib, TYK2 inhibitors such as deucravacitinib, or Chinese herbal medicines for psoriasis);
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- Use of natalizumab, or B-cell/T-cell modulators (e.g., rituximab, abatacept, visilizumab) within 12 months before the first administration of the investigational product;
- Received phototherapy for psoriasis within 1 month before the first administration of the study drug, and/or unwillingness to avoid prolonged sun exposure and other UV light sources (e.g., sunbathing/tanning devices) during the study;
- Received investigational biological agents within 6 months, any investigational therapy within 30 days, study drugs within 5 half-lives (whichever is longer), or current participation in clinical trials before the first administration of the investigational product.
Trial locations and contacts
1 site in 1 country.
China1 site
Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)
Jinan, Shandong, 250000
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Switching to Picankibart in Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.
- Conditions
- Plaque Psoriasis
- Being tested
- Picankibart, Secukinumab, Placebo, Ixekizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicankibartDrug
The participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32.
The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36.
SecukinumabDrug
The participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12.
PlaceboDrug
The participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36.
The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32.
IxekizumabDrug
The participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12.
| Study group | Role | What they receive |
|---|---|---|
| Picankibart treatment group | Experimental | The participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32. Receives: Drug: Picankibart; Drug: Placebo |
| IL-17 mAb continued treatment group | Active comparator | The participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36. Receives: Drug: Picankibart; Drug: Secukinumab; Drug: Placebo; Drug: Ixekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Measured: Week 16
Secondary outcomes (19)
The percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 16
The percentage of participants achieving a PASI 90 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 16
The percentage of participants achieving sPGA=0
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear.
Measured: Week 16
The percentage of participants with involved body surface area (BSA) <3% (or ≥75% reduction relative to baseline)
The area of involved body surface area (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 16
The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. The area of involved involved body surface area (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 16
The percentage of participants achieving Dermatology Life Quality Index (DLQI)=0/1 (for participants with baseline DLQI >1 only)
The Dermatology Life Quality Index (DLQI) is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Measured: Week 16
The percentage of participants achieving a PASI 100 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 16
The change from baseline in PASI score
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
Measured: Week 16
The change from baseline in involved BSA
The area of involved body surface area (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 16
The percentage of participants achieving sPGA=0/1
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
Measured: Week 44
The percentage of participants achieving sPGA=0
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear.
Measured: Week 44
The percentage of participants with involved BSA<3% (or ≥75% reduction relative to baseline)
The area of involved body surface area (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 44
The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear. The area of involved BSA will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 44
The percentage of participants achieving DLQI=0/1 (for participants with baseline DLQI >1 only)
The Dermatology Life Quality Index (DLQI) is a self-administered, 10-question questionnaire covering 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and bother with psoriasis treatment). The response options range from 0, not affected at all, to 3, very much affected. This gives an overall range of 0 to 30 where lower scores mean better quality of life.
Measured: Week 44
The percentage of participants achieving a PASI 75 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 44
The percentage of participants achieving a PASI 90 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 44
The percentage of participants achieving a PASI 100 response
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI 100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
Measured: Week 44
The change from baseline in PASI score
The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
Measured: Week 44
The change from baseline in involved BSA
The area of involved body surface area (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. The involved BSA ranges from 0% to 100%, where a lower BSA indicates less involved skin.
Measured: Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start27 May 2025
- Primary completion7 Jun 2026 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945107
- Sponsor's protocol ID
- CIBI112A303CN
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Switching to Picankibart in Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy
- ClinicalTrials.gov ID
- NCT06945107
- Acronym / sponsor ID
- CIBI112A303CN
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 25 Apr 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.
This multicenter, randomized, double-blind, active-controlled study aims to evaluate the efficacy and safety of picankibart in Chinese patients with plaque psoriasis who demonstrated inadequate responses to interleukin-17 (IL-17) monoclonal antibody therapy and subsequently switched to picankibart. The trial will enroll approximate 310 participants with confirmed plaque psoriasis diagnosis and a poor response to IL-17 monoclonal antibody treatment. The study includes a 4-week screening phase, followed by an active treatment period of either 36 weeks, and concludes with a safety follow-up assessment at Week 48.
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 |
|---|---|---|
| Picankibart treatment group | Experimental | Drug: Picankibart, Drug: PlaceboThe participants in this group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32. |
| IL-17 mAb continued treatment group | Active comparator | Drug: Picankibart, Drug: Secukinumab, Drug: Placebo, Drug: IxekizumabThe participants in this group will receive the original IL-17 mAb at Weeks 0, 4, 8 and 12, followed by picankibart 200mg SC at Weeks 16, 20, 24 and 36. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged ≥18 years and ≤75 years.
- Diagnosed with plaque psoriasis for ≥6 months, with or without psoriatic arthritis.
- Regular use of secukinumab or ixekizumab according to the label information for at least 16 weeks prior to baseline (actual dose received ≥80% of the standard dose per instructions during the 16 weeks before baseline), with sufficient documented rationale for medication use.
- At both screening and baseline, meet the criteria of sPGA (Static Physician's Global Assessment) ≥2 and body surface area (BSA) involvement ≥3%, along with the investigator's assessment of inadequate response to the original IL-17 monoclonal antibody therapy, warranting a switch to biologic treatment.
- Full understanding of the trial objectives, basic knowledge of the pharmacological effects and potential adverse reactions of the investigational product, and voluntary provision of written informed consent in accordance with the principles of the Helsinki Declaration.
Key exclusion criteria (9 listed)
- Diagnosed with guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis during screening or at baseline;
- Previous diagnosis of drug-induced psoriasis (e.g., psoriasis induced by beta blockers, calcium channel inhibitors, etc.);
- Prior use of picankibart or IL-23 inhibitors;
- Received two biological agents for psoriasis treatment within 16 weeks prior to screening;
- Received topical treatments that may affect psoriasis evaluation within 2 weeks before the first administration of the investigational product (including but not limited to glucocorticoids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, keratoplastics, and combination therapies);
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 |
|---|---|---|
| PicankibartThe participants in picankibart treatment group will receive picankibart 200mg SC at Weeks 0, 4, 8, 20 and 32. The participants in IL-17 mAb continued treatment group will receive picankibart 200mg SC at Weeks 16, 20, 24 and 36. | Drug | IL-17 mAb continued treatment group, Picankibart treatment group |
| SecukinumabThe participants in IL-17 mAb continued treatment group who have received secukinumab before enrollment, will receive secukinumab 300mg SC at Weeks 0, 4, 8 and 12. | Drug | IL-17 mAb continued treatment group |
| PlaceboThe participants in picankibart treatment group will receive placebo SC at Weeks 12, 16, 24 and 36. The participants in IL-17 mAb continued treatment group will receive placebo SC at Week 32. | Drug | IL-17 mAb continued treatment group, Picankibart treatment group |
| IxekizumabThe participants in IL-17 mAb continued treatment group who have received ixekizumab before enrollment, will receive ixekizumab 80mg SC at Weeks 0, 4, 8 and 12. | Drug | IL-17 mAb continued treatment group |
Primary outcome
The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1)
Time frame: Week 16
The static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
19 secondary outcomes
The percentage of participants achieving a Psoriasis Area and Severity Index (PASI) 75 response
Time frame: Week 16
The percentage of participants achieving a PASI 90 response
Time frame: Week 16
The percentage of participants achieving sPGA=0
Time frame: Week 16
The percentage of participants with involved body surface area (BSA) <3% (or ≥75% reduction relative to baseline)
Time frame: Week 16
The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)
Time frame: Week 16
The percentage of participants achieving Dermatology Life Quality Index (DLQI)=0/1 (for participants with baseline DLQI >1 only)
Time frame: Week 16
The percentage of participants achieving a PASI 100 response
Time frame: Week 16
The change from baseline in PASI score
Time frame: Week 16
The change from baseline in involved BSA
Time frame: Week 16
The percentage of participants achieving sPGA=0/1
Time frame: Week 44
The percentage of participants achieving sPGA=0
Time frame: Week 44
The percentage of participants with involved BSA<3% (or ≥75% reduction relative to baseline)
Time frame: Week 44
The percentage of participants achieving sPGA=0/1 and with involved BSA <3% (or ≥75% reduction relative to baseline)
Time frame: Week 44
The percentage of participants achieving DLQI=0/1 (for participants with baseline DLQI >1 only)
Time frame: Week 44
The percentage of participants achieving a PASI 75 response
Time frame: Week 44
The percentage of participants achieving a PASI 90 response
Time frame: Week 44
The percentage of participants achieving a PASI 100 response
Time frame: Week 44
The change from baseline in PASI score
Time frame: Week 44
The change from baseline in involved BSA
Time frame: Week 44
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 25 Mar 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.
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 3 study testing Picankibart, Secukinumab and Ixekizumab in people with Plaque Psoriasis, run by Innovent Biopharmaceutical Technology (Hangzhou) 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 9 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 25 Mar 2026. 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. 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?
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?
The percentage of participants achieving static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) (time frame: 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 25 Mar 2026.