A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis
NCT ID: NCT05645627
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2023-02-10
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48
placebo /IBI112
placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48
Group 2
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48
IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
Group 3
Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48
IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
Interventions
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IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
placebo /IBI112
placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48
IBI112
IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48
Eligibility Criteria
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Inclusion Criteria
2. Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)
Exclusion Criteria
2. Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
3. Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent
4. Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
5. Has received any conventional therapeutic agent within 1 months of the first administration of study agent
6. Has received any topic therapeutic agent within 2 weeks of the first administration of study agent
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CIBI112A301
Identifier Type: -
Identifier Source: org_study_id
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