Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Akeso Tiancheng, Inc | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK101 45mg every 8 weeks | Experimental | AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 8 weeks |
|
| AK101 45mg - every 12 weeks | Experimental | AK101 45mg on Week 0 and 4 administered subcutaneously followed by AK101 45mg administered subcutaneously every 12 weeks |
|
| AK101 90mg - every 8 weeks | Experimental | AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 8 weeks |
|
| AK101 90mg -every 12 weeks | Experimental | AK101 90mg on Week 0 and 4 administered subcutaneously followed by AK101 90mg administered subcutaneously every 12 weeks |
|
| AK101 135mg -every 8 weeks | Experimental | AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK101 | Biological | an anti-IL-12/23p40 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) at Week 12 | Week 12 | |
| Incidence of treatment emergent adverse events (TEAEs) | From the time of signing the informed consent form till last follow-up visit (Up to Week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) at Week 12 | At baseline and Week 12 | |
| Number of participants who achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI75) | Up to Week 52 (except for Week 12) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianzhong Zhang, MD | Peking University People's 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 | ||
| Peking University People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AK101 135mg -every 12 weeks |
| Experimental |
AK101 135mg on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously every 12 weeks |
|
| Placebo to AK101 | Placebo Comparator | Placebo on Week 0 and 4 administered subcutaneously followed by AK101 135mg administered subcutaneously at Week 12, 16 and then every 12 weeks |
|
| Placebo | Biological | matching placebo |
|
| Number of participants who achieved ≥ 90% reduction in Psoriasis Area and Severity Index (PASI90) | Up to Week 52( except for Week 12) |
| Number of participants who achieved 100% reduction in Psoriasis Area and Severity Index (PASI100) at Week 12 | Up to Week 52 |
| Proportion of subjects who achieve a ≥ 4-point reduction in DLQI from baseline | The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall Qol, can be used to assess six different aspects that mey affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. | Up to Week 52 |
| Proportion of subjects who achieve Physician Global Assessment (PGA) of clear or almost clear (0 or 1) after treatment | Up to Week 52 |
| 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) | Up to Week 52 |
| Minimum observed concentration (Cmin) of AK101 at steady state | Up to Week 52 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |