Psoriatic ArthritisPhase 2/3NCT07295509
A Study of Picankibart in Patients With Active Psoriatic Arthritis
A Phase 2/3 study testing Picankibart in people with Psoriatic Arthritis, run by Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Picankibart
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 31 Dec 2029
- Phase
- Phase 2/3
- 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
- Age 18-75 years
- Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
- Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
- Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
- Stable doses of protocol permitted background therapy (if any)
Who cannot join
- Other inflammatory conditions that may affect the evaluation of the study drug
- Prior treatment with >2 biologic agents
- Recent use of prohibited medications (specific washout periods apply)
- Non-plaque psoriasis forms or drug-induced psoriasis
- Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
- Significant laboratory abnormalities
- Pregnancy or breastfeeding
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
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xiaoyong Man, +86 57187783753, manxy@zju.edu.cn
Xiaoyong Man, M.D.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.
- Conditions
- Psoriatic Arthritis
- Being tested
- Placebo, Picankibart
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo administered SC at each scheduled dosing timepoint.
PicankibartDrug
Picankibart administered SC at each scheduled dosing timepoint.
| Study group | Role | What they receive |
|---|---|---|
| Picankibart Group 2 | Experimental | Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2. Receives: Other: Placebo; Drug: Picankibart |
| Placebo Group | Placebo comparator | Participants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26. Receives: Other: Placebo; Drug: Picankibart |
| Picankibart Group 1 | Experimental | Participants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1. Receives: Drug: Picankibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response
The ACR20 response is defined as ≥20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥20% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Measured: Week 26
Secondary outcomes (14)
Change from baseline in Disease Activity Score in 28 Joints (DAS28)-CRP score
The DAS28-CRP is a measure of disease activity based on swollen and tender joint counts in 28 joints, CRP and the participant's global assessment of disease activity. The range of DAS28-CRP score is 0-10. Higher score means more disease activity.
Measured: Week 26, and from baseline to Week 56
Percentage of participants who achieved an ACR50 response
The ACR50 response is defined as ≥50% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥50% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Measured: Week 26, and from baseline to Week 56
Percentage of participants who achieved an ACR70 response
The ACR70 response is defined as ≥70% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥70% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
Measured: Week 26, and from baseline to Week 56
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI measures improvement in physical function/disability. It is defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area.
Measured: Week 26, and from baseline to Week 56
Change from baseline in Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) score
The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100) and a positive change from Baseline indicates improvement.
Measured: Week 26, and from baseline to Week 56
Enthesitis/dactylitis resolution rates
Percentage of participants with complete resolution of enthesitis (inflammation at tendon/ligament attachments) or dactylitis (sausage-digit swelling).
Measured: Week 26, and from baseline to Week 56
Percentage of participants who achieved 75%Psoriasis Area and Severity Index 75 response
Percentage of participants who achieve at least 75% or 90% or 100% reduction in Psoriasis Area and Severity Index (PASI) score, assessing skin lesion severity in psoriatic arthritis patients.
Measured: From baseline to Week 56
Change from baseline in van der Heijde-modified Total Sharp Score (vdH-mTSS)
The vdH-mTSS is a measure of change in joint health. X-rays of hands and feet are obtained at screening, Week 26 and Week 56. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the vdH-mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in vdH-mTSS from baseline represents disease progression and/or joint worsening.
Measured: Week 26 and Week 56
Percentage of participants who experienced adverse events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.
Measured: From baseline to Week 56
Percentage of participants who experienced serious adverse events (SAEs)
An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.
Measured: From baseline to Week 56
Maximum plasma concentration (Cmax) of picankibart
Plasma concentration of picankibart is evaluated at each scheduled dosing timepoint. Cmax is the highest concentration of a drug in the blood.
Measured: From baseline to Week 56
Area under the concentration-time curve (AUC) of picankibart
Plasma concentration of picankibart is evaluated at each scheduled dosing timepoint. AUC represents the area under the concentration-time curve and gives insight into the extent of exposure to a drug and its clearance rate from the body.
Measured: From baseline to Week 56
Percentage of participants who developed anti-drug antibody (ADA)
ADAs are immune system-produced antibodies that specifically bind to therapeutic drugs, potentially altering their pharmacokinetics, efficacy, or safety.
Measured: From baseline to Week 56
Percentage of participants who developed neutralizing antibody (NAb)
NAbs are ADAs that inhibit the drug's biological function by blocking target interaction.
Measured: From baseline to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start18 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 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
- NCT07295509
- Sponsor's protocol ID
- CIBI112C301
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 20 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Picankibart in Patients With Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT07295509
- Acronym / sponsor ID
- CIBI112C301
- Conditions
- Psoriatic Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with active psoriatic arthritis (PsA). The study consists of two stages: Phase II dose-finding (n=90) and Phase III confirmatory (n=132). Participants will receive subcutaneous (SC) injections of either picankibart (200mg) or placebo with different dosing schedules, with placebo crossover to active treatment at Week 26. The Phase II portion will identify optimal dosing for Phase III, which will confirm efficacy. The study will evaluate improvements in joint symptoms, physical function, quality of life, and skin manifestations. Primary endpoint is percentage of participants who achieved an American College of Rheumatology (ACR) 20 Response at Week 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Picankibart Group 2 | Experimental | Other: Placebo, Drug: PicankibartParticipants receive picankibart SC at each scheduled dosing timepoint with dosing interval 2. |
| Placebo Group | Placebo comparator | Other: Placebo, Drug: PicankibartParticipants receive placebo SC at each scheduled dosing timepoint. Treatment of picankibart starts at Week 26. |
| Picankibart Group 1 | Experimental | Drug: PicankibartParticipants receive picankibart SC at each scheduled dosing timepoint with dosing interval 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years
- Diagnosed with PsA for ≥3 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
- Having active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline
- Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis, or a documented history of plaque psoriasis
- Inadequate response or intolerance to prior NSAIDs or non-biologic DMARDs
Key exclusion criteria (7 listed)
- Other inflammatory conditions that may affect the evaluation of the study drug
- Prior treatment with >2 biologic agents
- Recent use of prohibited medications (specific washout periods apply)
- Non-plaque psoriasis forms or drug-induced psoriasis
- Severe, progressive, or uncontrolled renal, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, hematological, rheumatic (excluding PsA), psychiatric, or genitourinary conditions
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 |
|---|---|---|
| PlaceboPlacebo administered SC at each scheduled dosing timepoint. | Other | Picankibart Group 2, Placebo Group |
| PicankibartPicankibart administered SC at each scheduled dosing timepoint. | Drug | Picankibart Group 1, Picankibart Group 2, Placebo Group |
Primary outcome
Percentage of participants who achieved an American College of Rheumatology (ACR) 20 response
Time frame: Week 26
The ACR20 response is defined as ≥20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and ≥20% improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and C-reactive protein (CRP).
14 secondary outcomes
Change from baseline in Disease Activity Score in 28 Joints (DAS28)-CRP score
Time frame: Week 26, and from baseline to Week 56
Percentage of participants who achieved an ACR50 response
Time frame: Week 26, and from baseline to Week 56
Percentage of participants who achieved an ACR70 response
Time frame: Week 26, and from baseline to Week 56
Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time frame: Week 26, and from baseline to Week 56
Change from baseline in Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) score
Time frame: Week 26, and from baseline to Week 56
Enthesitis/dactylitis resolution rates
Time frame: Week 26, and from baseline to Week 56
Percentage of participants who achieved 75%Psoriasis Area and Severity Index 75 response
Time frame: From baseline to Week 56
Change from baseline in van der Heijde-modified Total Sharp Score (vdH-mTSS)
Time frame: Week 26 and Week 56
Percentage of participants who experienced adverse events (AEs)
Time frame: From baseline to Week 56
Percentage of participants who experienced serious adverse events (SAEs)
Time frame: From baseline to Week 56
Maximum plasma concentration (Cmax) of picankibart
Time frame: From baseline to Week 56
Area under the concentration-time curve (AUC) of picankibart
Time frame: From baseline to Week 56
Percentage of participants who developed anti-drug antibody (ADA)
Time frame: From baseline to Week 56
Percentage of participants who developed neutralizing antibody (NAb)
Time frame: From baseline to 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 20 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Picankibart in people with Psoriatic Arthritis, 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 6 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: looking for participants now, as of the sponsor's last update on 20 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. 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 combined 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.
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 participants who achieved an American College of Rheumatology (ACR) 20 response (time frame: Week 26). 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 20 Mar 2026.