PsoriasisPhase 3NCT07265284
A Study to Evaluate Efficacy and Safety of IBI112 in Adolescent Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing IBI112 in people with Psoriasis, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis. Read more about this study
- Who is it for?
- Ages 12 to 18 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
- 104 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2025to 31 Jan 2029
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and/or systemic treatment for psoriasis.
Who cannot join
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent Hsa received IBI112
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100000
Zigang Xu, +86 1337011021, zigangxupek@163.com
About this study
Official title: A Phase Ⅰ/Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type psoriasis.
- Conditions
- Psoriasis
- Being tested
- 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
IBI112 by subcutaneous injection
placeboDrug
placebo by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44 Receives: Drug: placebo |
| IBI112 | Experimental | Participants receive IBI112 through week 44 Receives: Drug: IBI112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Measured: week 16
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Measured: week 16
Secondary outcomes (10)
Percentage of patients achieving PASI 50 at week 16
PASI 50 is defined as at least a 50% reduction in PASI relative to baseline
Measured: week 16
Percentage of patients achieving PASI 90 at week 16
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Measured: week 16
Percentage of patients achieving PASI 100 at week 16
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Measured: week 16
Percentage of patients achieving an sPGA 0 at week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Measured: week 16
Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16
The CDLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life
Measured: week 16
Percentage of patients achieving PASI 75 at week 56
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Measured: week 56
Percentage of patients achieving PASI 90 at week 56
PASI 90 is defined as at least a 90% reduction in PASI relative to baseline
Measured: week 56
Percentage of patients achieving PASI 100 at week 56
PASI 100 is defined as at least a 100% reduction in PASI relative to baseline
Measured: week 56
Percentage of patients achieving an sPGA 0/1 at Week 56
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
Measured: week 56
Percentage of patients achieving an sPGA 0 at Week 56
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
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 posted4 Dec 2025
- Study start3 Dec 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Jan 2029 (estimated)
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.
- 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
- 104 participants (estimated)
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
- NCT07265284
- Sponsor's protocol ID
- CIBI112A304
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ/Ⅲ Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Picankibart in Adolescent Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07265284
- Acronym / sponsor ID
- CIBI112A304
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 4 Dec 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 purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of adolescent participants with moderate to severe plaque-type 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 |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboParticipants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 44 |
| IBI112 | Experimental | Drug: IBI112Participants receive IBI112 through week 44 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Males or females aged 12 to 18 years; Diagnosed with plaque psoriasis and a history of psoriasis ≥6 months; suitable for phototherapy and/or systemic treatment for psoriasis.
Key exclusion criteria (1 listed)
- History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent Hsa received IBI112
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 |
|---|---|---|
| IBI112IBI112 by subcutaneous injection | Drug | IBI112 |
| placeboplacebo by subcutaneous injection | Drug | placebo |
Primary outcome
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
Time frame: week 16
PASI 75 is defined as at least a 75% reduction in PASI relative to baseline
Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
Time frame: week 16
sPGA of psoriasis is used to determine the participant's psoriasis lesions overall.
10 secondary outcomes
Percentage of patients achieving PASI 50 at week 16
Time frame: week 16
Percentage of patients achieving PASI 90 at week 16
Time frame: week 16
Percentage of patients achieving PASI 100 at week 16
Time frame: week 16
Percentage of patients achieving an sPGA 0 at week 16
Time frame: week 16
Percentage of patients achieving an Children Dermatology life quality index (CDLQI) Score of 0 /1at week 16
Time frame: week 16
Percentage of patients achieving PASI 75 at week 56
Time frame: week 56
Percentage of patients achieving PASI 90 at week 56
Time frame: week 56
Percentage of patients achieving PASI 100 at week 56
Time frame: week 56
Percentage of patients achieving an sPGA 0/1 at Week 56
Time frame: week 56
Percentage of patients achieving an sPGA 0 at Week 56
Time frame: week 56
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 22 Dec 2025.
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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.
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 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Dec 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?
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?
Contact Bingjing Feng (+86 18361923769, bingjing.feng@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16 (time frame: week 16). 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?
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 22 Dec 2025.