Moderate to severe plaque psoriasis
Conditions
Interventions
Phase ?-IBI112:receive IBI112 from week 0 and maintain the medication every 12 weeks until week 44.
Phase ?-IBI112-Group:receive IBI112 from week 0 and maintain the medication every 12 weeks until week 44.
Phase ?-placebo group:receive IBI112 from week 16 and maintain the medication every 12 weeks until week 44.
Sponsors
Beijing Children's Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged 12 years or older but under 18 years of age; 2. Diagnosed with plaque psoriasis and a history of psoriasis >= 6 months; 3. At screening and baseline, plaque psoriasis must involve >= 10% Body Surface Area (BSA), have a Psoriasis Area and Severity Index (PASI) score >= 12, and achieve a Static Physician Global Assessment (sPGA) score >= 3; 4. The subject is deemed suitable for phototherapy and/or systemic treatment for psoriasis by the investigator; 5. The subject can communicate effectively with the investigator, understands and is willing to comply with the study requirements; the subject and their parent or legal guardian consent to participate in this study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of psoriasis types other than plaque psoriasis (guttate psoriasis, pustular psoriasis, or erythrodermic psoriasis); 2.Diagnosed with drug-induced psoriasis (e.g., psoriasis caused by beta-blockers, calcium channel blockers, etc.); 3.Previous use of IBI112; 4.Received topical treatments within 2 weeks prior to first study drug administration that may affect psoriasis assessment (including but not limited to corticosteroids, vitamin D3 derivatives, retinoids, calcineurin inhibitors, keratolytics, and combination formulations); 5.Received systemic medications within 4 weeks prior to the first dose of study drug that may affect psoriasis assessment (including but not limited to methotrexate, cyclosporine, retinoids, azathioprine, leflunomide, mycophenolate mofetil, sulfasalazine, glucocorticoids, JAK inhibitors such as tofacitinib or baricitinib, or traditional Chinese medicine or proprietary Chinese preparations used to treat psoriasis); 6.Received tumor necrosis factor-a (TNF-a) antagonists (including but not limited to etanercept, infliximab, adalimumab) within 3 months prior to the first use of the study drug (or within 5 half-lives of the drug); 7.Received treatment targeting IL-17 or IL-23 (including but not limited to secukinumab, ixekizumab, ustekinumab, guselkumab, etc.) within 6 months prior to the first use of the study drug (or within 5 half-lives of the drug); 8.Use of natalizumab, or B-cell or T-cell modulators (e.g., rituximab, abatacept, or visilizumab) within 12 months prior to first study drug administration; 9.Use of phototherapy for psoriasis within 1 month prior to first study drug administration, and/or unwillingness to avoid prolonged sun exposure and other sources of ultraviolet light during the study period; 10.Evidence indicates the subject has severe, progressive, uncontrolled (including but not limited to) cardiovascular disease, neuromuscular disease, hematologic disease, respiratory disease, hepatic or gastrointestinal disease, urological disease, neurological or psychiatric disease, or a history thereof; 11.History of opportunistic infections prior to screening [e.g., herpes zoster (recurrent), active cytomegalovirus, Pneumocystis carinii, histoplasmosis, aspergillosis, mycobacterial infections, etc.]; 12.Known history of recurrent or chronic infections, including but not limited to: chronic kidney infections, chronic chest infections (e.g., bronchiectasis), recurrent urinary tract infections, open wounds, draining wounds, or infected skin wounds; 13.History of severe infection (e.g., sepsis, pneumonia, pyelonephritis), or hospitalization or intravenous antibiotic treatment for infection within 2 months prior to screening; 14.Presence or history of lymphoproliferative disorders, or symptoms or signs suggestive of lymphoproliferative disease within 5 years prior to screening, such as lymphadenopathy and/or splenomegaly; 15.Subjects with a known history of active tuberculosis, those with chest imaging findings suggestive of tuberculosis, or those presenting with clinical manifestations suggestive of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.). For subjects not meeting the above criteria, eligibility for study participation will be assessed based on Interferon Gamma Release Assay (IGRA) results: IGRA result is negative, meeting eligibility criteria; IGRA result is indeterminate, retesting may be performed; if retest remain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I- All adverse events, serious adverse events, etc. Changes in vital signs, laboratory tests, electrocardiograms, etc., before and after administration;Phase ?- Proportion of subjects achieving >= 75% PASI improvement (PASI 75) at Week 16;Phase ?- Proportion of subjects achieving clear (score 0) or almost clear (score 1) on the static Physician’s Global Assessment (sPGA) at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I- Proportion of subjects achieving >= 75% PASI improvement (PASI 75) at each time point;Phase I- Proportion of subjects achieving clear (score 0) or almost clear (score 1) on the static Physician’s Global Assessment (sPGA) at each time point;Phase I- Proportion of subjects achieving >= 50% PASI improvement (PASI 50) at each time point;Phase I- Proportion of subjects achieving >= 90% PASI improvement (PASI 90) at each time point;Phase I- Proportion of subjects achieving 100% PASI improvement (PASI 100) at each time point;Phase I- Proportion of subjects achieving clear (score 0) on the static Physician’s Global Assessment (sPGA) at each time point;Phase I- Proportion of participants scoring 0/1 on the Children’s Dermatology Life Quality Index (CDLQI) at each time point;Phase I- Change in PASI relative to baseline at each time point;Phase I- Proportion of subjects achieving 75%, 90%, and 100% improvement in the Psoriasis Scalp Severity Index (PSSI) relative to baseline at each time point (limited to subjects with concomitant scalp psoriasis at baseline);Phase I- Change in Nail Psoriasis Severity Index (NAPSI) relative to baseline at each time point (limited to subjects with nail psoriasis at baseline);Phase I- Proportion of participants scoring 0/1 on the static Physician’s Global Assessment of Genitalia (sPGA-G) at each time point (limited to subjects with genital psoriasis at baseline);Phase I- Proportion of subjects achieving 75%, 90%, and 100% improvement in the Palmoplantar Psoriasis Severity Index (PPASI) relative to baseline at each time point (limited to subjects with concomitant palmoplantar psoriasis at baseline);Phase ?- Proportion of subjects achieving >= 50% PASI improvement (PASI 50) at Week 16;Phase ?- Proportion of subjects achieving >= 90% PASI improvement (PASI 90) at Week 16;Phase ?- Proportion of subjects achieving 100% PASI improvement (PASI 100) at Week 16;Phase ?- Proportion of subjects achieving clear (score 0) on the static Physician’s | — |
Countries
China
Contacts
Public ContactZigang Xu
Beijing Children's Hospital Affiliated to Capital Medical University
Outcome results
None listed