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| Name | Class |
|---|---|
| Akeso Tiancheng, Inc | OTHER |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and the preliminary efficacy of AK101,an anti-IL-12/23p40 monoclonal antibody, when administered subcutaneously in subjects with moderate-to-severe plaque psoriasis.
This was a single-center, randomized, double-blind, placebo-controlled trial which consisted of a dose escalation phase (Phase I) and a dose expansion phase (Phase II)..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: AK101 45 mg | Experimental | Biological: AK101 AK101 45 mg on Week 0 and 4 by subcutaneous injection |
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| Phase I: AK101 135 mg | Experimental | Biological: AK101 AK101 135 mg on Week 0 and 4 by subcutaneous injection |
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| Phase I: AK101 270 mg | Experimental | Biological: AK101 AK101 270 mg on Week 0 and 4 by subcutaneous injection |
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| Phase I: Placebo | Placebo Comparator | Biological: Placebo Placebo on Week 0 and 4 by subcutaneous injection |
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| Phase II: AK101 45 mg | Experimental | Biological: AK101 AK101 45 mg on Week 0, 4 and 16 by subcutaneous injection |
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| Phase II: AK101 90 mg | Experimental | Biological: AK101 AK101 90 mg on Week 0, 4 and 16 by subcutaneous injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK101 | Biological | AK101 is an anti-IL-12/23p40 monoclonal antibody. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events (TEAEs) | From the time of signing informed consent till Week 16 for Phase I or Week 28 for Phase II |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) | At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II) | |
| Number of participants who achieved ≥ 90% reduction in PASI (PASI90) | At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rui Chen, MD | Peking Union Medical College Hospital | Principal Investigator |
| Hongzhong Jin, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
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| Phase II: AK101 135 mg | Experimental | Biological: AK101 AK101 135 mg on Week 0, 4 and 16 by subcutaneous injection |
|
| Phase II: Placebo to AK101 | Placebo Comparator | Drug: Placebo Placebo on Week 1 and 4 by subcutaneous injection, and then AK101 on Week 12 16 by subcutaneous injection |
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| placebo | Biological | matching placebo |
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| Change From Baseline in the Physician Global Assessment (PGA) | At Week 2, 4, 8, 12, 16, 20 (Phase II), 24 (Phase II) and 28 (Phase II) |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | The immunogenicity of AK101 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). | From first dose till Week 16 for Phase I or Week 28 for Phase II |
| Area under the curve (AUC) of AK101 | The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration. | From first dose till Week 16 for Phase I |
| Minimum observed concentration (Cmin) of AK101 | The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration. | From first dose till Week 16 for Phase I or Week 28 for Phase II |
| Maximum observed concentration (Cmax) of AK101 | The endpoints for assessment of PK of AK101 include serum concentrations of AK101 at different timepoints after AK101 administration. | From first dose till Week 16 for Phase I or Week 28 for Phase II |