IBI112 for adolescents with moderate to severe plaque psoriasis
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
This trial will test whether the drug IBI112 can improve skin symptoms and is safe for adolescents aged 12–18 who have moderate to severe plaque psoriasis compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07265284 on ClinicalTrials.gov |
What this trial studies
This is a Phase 3 interventional trial sponsored by Innovent Biopharmaceuticals conducted at Beijing Children's Hospital for adolescents with moderate to severe plaque-type psoriasis. Eligible participants aged 12–18 with at least a 6-month history of psoriasis will receive either IBI112 or a matching placebo and be followed over the treatment period. The protocol excludes those with certain psoriasis subtypes, recent targeted biologic therapy, or uncontrolled serious medical conditions. Efficacy will be measured by dermatologic outcomes and safety will be monitored through regular clinic visits and adverse event reporting.
Who should consider this trial
Good fit: Adolescents aged 12 to 18 with a confirmed history of plaque psoriasis for at least 6 months who are suitable for phototherapy and/or systemic treatment are the intended participants.
Not a fit: Patients with erythrodermic, pustular, medication-induced psoriasis, new-onset guttate psoriasis, recent IL-17 or TNF-alpha targeted therapy, or uncontrolled serious medical conditions are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, IBI112 could reduce psoriasis symptoms and improve quality of life for adolescents with moderate to severe plaque psoriasis.
How similar studies have performed: Other biologic therapies targeting inflammatory pathways have shown strong results in adolescents with moderate to severe plaque psoriasis, so this approach builds on existing successful strategies though IBI112 itself is a novel agent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Children's Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Bingjing Feng
- Email: bingjing.feng@innoventbio.com
- Phone: +86 18361923769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.