PsoriasisPhase 2NCT05970978
A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics
A Phase 2 study testing regular treatment and Intensive treatment in people with Psoriasis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- regular treatment and Intensive treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2023to 26 Jan 2025
- 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
- 18 to 75 years old;
- Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
- Received previous biologic therapy with at least 4 months.
Who cannot join
- Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
- Previously treated with IBI112 or other IL-23 inhibitors;
- Treated with two biologics for psoriasis within 4 months prior to screening;
- Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
- Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
- Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
- Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.
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 Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112
This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.
- Conditions
- Psoriasis
- Being tested
- regular treatment, Intensive treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regular treatmentDrug
Also called Response to previous biologic therapy
IBI112 200mg s.c. at week 0, 12, 24 and 36.
Intensive treatmentDrug
Also called Poor response to previous biologic therapy
IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.
| Study group | Role | What they receive |
|---|---|---|
| Response to previous biologic therapy | Experimental | Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36. Receives: Drug: regular treatment |
| Poor response to previous biologic therapy | Experimental | Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32. Receives: Drug: Intensive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%
Measured: Week 16
Secondary outcomes (4)
Percentage of participants who achieve sPGA clean (0) at Week 16.
Measured: Week 16
Percentage of participants with a DLQI score of 0/1 at Week 16.
Measured: Week 16
Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
Measured: Week 44
Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44
Measured: Week 16 up to Week 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start28 Aug 2023
- Primary completion19 Jul 2024
- Study completion26 Jan 2025
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970978
- Sponsor's protocol ID
- CIBI112A202CN
- Status last verified
- Apr 2025
- First submitted
- 24 Jul 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Q, Yang B, Gu H, Wu L, Qin L, Wang L, Li Y, Gu L, Shen Z, Zhang S, Lu J, Shi Y, Tao X, Cui Y, Zhang S, Ren H, Li L, Man X, Chen H, Xiao R, Yang Z, Ren Y, Ye R, Du H, Zhang F. Efficacy and Safety of Switching to Picankibart from Non-interleukin-23 Subunit p19 Inhibitors in Patients with Plaque Psoriasis: A Multicenter, Open-Label, Phase 2 Trial. Adv Ther. 2026 Mar;43(3):1274-1289. doi: 10.1007/s12325-025-03419-w. Epub 2026 Jan 27.
PubMed 41591649
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112
- ClinicalTrials.gov ID
- NCT05970978
- Acronym / sponsor ID
- CIBI112A202CN
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 2 Aug 2023 (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 is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Response to previous biologic therapy | Experimental | Drug: regular treatmentParticipants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36. |
| Poor response to previous biologic therapy | Experimental | Drug: Intensive treatmentParticipants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years old;
- Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
- Received previous biologic therapy with at least 4 months.
Key exclusion criteria (7 listed)
- Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
- Previously treated with IBI112 or other IL-23 inhibitors;
- Treated with two biologics for psoriasis within 4 months prior to screening;
- Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
- Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
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 |
|---|---|---|
| regular treatmentAlso: Response to previous biologic therapyIBI112 200mg s.c. at week 0, 12, 24 and 36. | Drug | Response to previous biologic therapy |
| Intensive treatmentAlso: Poor response to previous biologic therapyIBI112 200mg s.c. at week 0, 4, 8, 20 and 32. | Drug | Poor response to previous biologic therapy |
Primary outcome
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%
Time frame: Week 16
4 secondary outcomes
Percentage of participants who achieve sPGA clean (0) at Week 16.
Time frame: Week 16
Percentage of participants with a DLQI score of 0/1 at Week 16.
Time frame: Week 16
Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
Time frame: Week 44
Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44
Time frame: Week 16 up to Week 44
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 27 Apr 2025.
- Derived from this study: PubMed 41591649Yang Q, Yang B, Gu H, Wu L, Qin L, Wang L, Li Y, Gu L, Shen Z, Zhang S, Lu J, Shi Y, Tao X, Cui Y, Zhang S, Ren H, Li L, Man X, Chen H, Xiao R, Yang Z, Ren Y, Ye R, Du H, Zhang F. Efficacy and Safety of Switching to Picankibart from Non-interleukin-23 Subunit p19 Inhibitors in Patients with Plaque Psoriasis: A Multicenter, Open-Label, Phase 2 Trial. Adv Ther. 2026 Mar;43(3):1274-1289. doi: 10.1007/s12325-025-03419-w. Epub 2026 Jan 27.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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 regular treatment and Intensive treatment in people with Psoriasis, run by Innovent Biologics (Suzhou) 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 3 inclusion and 7 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 27 Apr 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. 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?
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3% (time frame: Week 16). 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 NCT05970978, 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 27 Apr 2025.