PsoriasisPhase 3NCT06049810
IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
A Phase 3 study testing IBI112 in people with Psoriasis, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe 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?
- IBI112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 566 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2023to 28 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of plaque-type psoriasis for at least 6 months;
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
- Must be a candidate for either systemic therapy or phototherapy for psoriasis.
Who cannot join
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Participants who have ever received IBI112 or IL-23 inhibitor
- History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis
- Conditions
- Psoriasis
- Being tested
- IBI112, IBI112/placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI112Drug
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112/placeboDrug
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 by subcutaneous injection
IBI112/placeboDrug
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
IBI112Drug
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44
IBI112Drug
Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
IBI112Drug
Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 3 | Experimental | Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44 Receives: Drug: IBI112 |
| Group 4 | Experimental | Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44 Receives: Drug: IBI112 |
| Group 6 | Experimental | Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44 Receives: Drug: IBI112 |
| Group 5 | Placebo comparator | Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44 Receives: Drug: IBI112/placebo |
| Group 1 | Experimental | Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 Receives: Drug: IBI112 |
| Group 2 | Placebo comparator | Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 Receives: Drug: IBI112/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
Measured: Week 56
Secondary outcomes (8)
Percentage of participants with a PASI75 Response
Measured: Week 56
Percentage of participants with a PASI100 Response
Measured: Week 56
Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1
Measured: Week 56
Percentage of participants with Dermatology Life Quality Index (DLQI) Score
Measured: Week 56
Percentage of participants with a sIGA score of 0
Measured: Week 56
Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response
Measured: Week 56
Changes of PASI Scores participants who relapse and retreatment
Measured: Week 56
Changes of sIGA score in participants who relapse and retreatment
Measured: Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start10 Oct 2023
- Primary completion29 Apr 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 566 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
- NCT06049810
- Sponsor's protocol ID
- CIBI112A302CN
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2023
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT06049810
- Acronym / sponsor ID
- CIBI112A302CN
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 22 Sep 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.
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 3 | Experimental | Drug: IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44 |
| Group 4 | Experimental | Drug: IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44 |
| Group 6 | Experimental | Drug: IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44 |
| Group 5 | Placebo comparator | Drug: IBI112/placeboParticipants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44 |
| Group 1 | Experimental | Drug: IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 |
| Group 2 | Placebo comparator | Drug: IBI112/placeboParticipants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of plaque-type psoriasis for at least 6 months;
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
- Must be a candidate for either systemic therapy or phototherapy for psoriasis.
Key exclusion criteria (5 listed)
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
- Participants who have ever received IBI112 or IL-23 inhibitor
- History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
- Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration 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 |
|---|---|---|
| IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44 | Drug | Group 3 |
| IBI112/placeboParticipants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44 by subcutaneous injection | Drug | Group 2 |
| IBI112/placeboParticipants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44 | Drug | Group 5 |
| IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44 | Drug | Group 6 |
| IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44 | Drug | Group 4 |
| IBI112Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44 by subcutaneous injection | Drug | Group 1 |
Primary outcome
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
Time frame: Week 56
8 secondary outcomes
Percentage of participants with a PASI75 Response
Time frame: Week 56
Percentage of participants with a PASI100 Response
Time frame: Week 56
Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1
Time frame: Week 56
Percentage of participants with Dermatology Life Quality Index (DLQI) Score
Time frame: Week 56
Percentage of participants with a sIGA score of 0
Time frame: Week 56
Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response
Time frame: Week 56
Changes of PASI Scores participants who relapse and retreatment
Time frame: Week 56
Changes of sIGA score in participants who relapse and retreatment
Time frame: Week 56
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 17 Aug 2025.
- Individual participant dataSharing planned: No
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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 IBI112 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 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: finished, as of the sponsor's last update on 17 Aug 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 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?
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 with a Psoriasis Area and Severity Index (PASI) 90 Response (time frame: Week 56). 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 17 Aug 2025.