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This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 for the treatment of moderate to severe plaque psoriasis.
This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical study to evaluate the efficacy and safety of AK111 in subjects with moderate to severe plaque psoriasis. The study will consist of 4 periods: up to 4 weeks screening period, 12 weeks placebo-controlled period,12 weeks crossover treatment period,44 weeks long-term treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK111 Regimen 1 | Experimental | AK111 Regimen 1 - subcutaneous injection every 4 weeks up to 60 weeks |
|
| AK111 Regimen 2 | Experimental | AK111 Regimen 2 - subcutaneous injection every 4 weeks up to 60 weeks |
|
| AK111 Regimen 3 | Experimental | AK111 Regimen 3 - subcutaneous injection every 4 weeks up to 60 weeks |
|
| AK111 Regimen 4 | Experimental | AK111 Regimen 4 - subcutaneous injection every 4 weeks up to 60 weeks |
|
| Placebo to AK111 | Placebo Comparator | Placebo to AK111-Placebo subcutaneous injection, then 1:1 randomized to AK111 Regimen 3 or Regimen 4 at week 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK111/Placebo | Biological | After loading dose, investigational drug was administered subcutaneously up to 60 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve Psoriasis Area and Severity Index (PASI) 90 response or higher at week 12 | At week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who achieve PASI 75 response or higher at week 12 | At week 12 | |
| Proportion of subjects who achieve static Physician Global Assessment (sPGA) 0 or 1 at week 12 | At week 12 | |
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Key Inclusion Criteria:
Male or female, 18 to 75 years of age
Moderate to severe plaque-type psoriasis diagnosed for at least 6 months
Moderate-to-severe plaque psoriasis as defined at baseline by meeting all three criteria:
Subjects with a history of an inadequate response, intolerable or medically inappropriate use of systemic therapy and/or phototherapy.
Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 8 months after the last study drug administration.
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AkesoBio Investigative Site 1011 | Bengbu | Anhui | China | |||
| AkesoBio Investigative Site 1009 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Proportion of subjects who achieve PASI 50, PASI 75, PASI 90 and PASI 100 response up to 68 weeks |
| Baseline to week 68 |
| AK111 concentrations in serum at different time points | Baseline to week 68 |
| Number and proportion of subjects who developed anti-drug antibodies (ADAs) | Baseline to week 68 |
| Change in serum IL-17A level (Pharmacodynamics parameter) | Baseline to week 68 |
| Adverse events (AEs)/serious adverse events (SAEs) | Baseline to week 68 |
| Beijing |
| Beijing Municipality |
| China |
| AkesoBio Investigative Site 1016 | Beijing | Beijing Municipality | China |
| AkesoBio Investigative Site 1003 | Guangzhou | Guangdong | China |
| AkesoBio Investigative Site 1007 | Guangzhou | Guangdong | China |
| AkesoBio Investigative Site 1012 | Chengde | Hebei | China |
| AkesoBio Investigative Site 1018 | Harbin | Heilongjiang | China |
| AkesoBio Investigative Site 1008 | Changsha | Hunan | China |
| AkesoBio Investigative Site 1013 | Yancheng | Jiangsu | China |
| AkesoBio Investigative Site 1001 | Shanghai | Shanghai Municipality | China |
| AkesoBio Investigative Site 1010 | Shanghai | Shanghai Municipality | China |
| AkesoBio Investigative Site 1002 | Hanzhou | Zhejiang | China |
| AkesoBio Investigative Site 1006 | Ningbo | Zhejiang | China |