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A multicenter clinical study to evaluate the safety, PK characteristics, immunogenicity characteristics, and PD characteristics of IBI3013 in healthy trial participants and active non-segmental vitiligo trial participants and severe alopecia areata trial participants. The study is divided into 2 parts, with Part 1 involving healthy trial participants lasting up to 24 weeks, and Part 2 involving active non-segmental vitiligo trial participants and severe alopecia areata trial participants lasting up to 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib tablets | Active Comparator | oral, 2mg, once daily |
|
| placebo | Placebo Comparator | subcutaneous injection/intravenous infusion,single or multiple dosing |
|
| IBI3013 | Experimental | subcutaneous injection/intravenous infusion,single or multiple dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo |
| |
| Baricitinib tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of participants with at least one treatment-emergent adverse event | up to 24 weeks | |
| Part 1: Number of participants with at least one Serious treatment-emergent adverse event | up to 24 weeks | |
| Part 2: Number of participants with at least one treatment-emergent adverse event | up to 48 weeks | |
| Part 2: Number of participants with at least one Serious treatment-emergent adverse event | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Cmax following a single dose of IBI3013. | up to 24 weeks | |
| Part 1: Tmax following a single dose of IBI3013. | up to 24 weeks | |
| Part 1: AUC following a single dose of IBI3013. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| juan chen | Contact | 021 3183 7200 | juan.chen01@innoventbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| Drug |
Baricitinib tablets |
|
| IBI3013 | Drug | Recombinant anti-Interleukin-15 (IL-15) monoclonal antibody injection |
|
| up to 24 weeks |
| Part 1: Cmin following a single dose of IBI3013. | up to 24 weeks |
| Part 1: CL/F or CL following a single dose of IBI3013. | up to 24 weeks |
| Part 1: Vd/F or Vd following a single dose of IBI3013. | up to 24 weeks |
| Part 1: T1/2 following a single dose of IBI3013. | up to 24 weeks |
| Part 1: Positive rate of anti-drug antibody following a single dose of IBI3013. | up to Day85 |
| Part 2: Cmax following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: Tmax following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: AUC following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: Cmin following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: CL/F following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: Vd/F following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: T1/2 following multiple doses of IBI3013. | up to 48 weeks |
| Part 2: Positive rate of anti-drug antibody following multiple doses of IBI3013. | up to 28 weeks |
| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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