Moderate to Severe Plaque Psoriasis Clinical Trial
Official title:
A Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy of Brodalumab (KHK4827) in Subjects With Moderate to Severe Plaque Psoriasis
| Verified date | September 2021 |
| Source | Kyowa Kirin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is assessing the efficacy and safety of brodalumab in Chinese subjects with moderate to severe plaque psoriasis.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2022 |
| Est. primary completion date | February 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Those who are =18 and =70 years of age at the time of signing the written informed consent form - Those who have involved BSA (the percentage (%) of body surface area involved with lesion) =10%, PASI (Psoriasis Area and Severity Index) =12 and sPGA (static Physician's global assessment) = 3 at screening and at baseline. Exclusion Criteria: - Those who diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis or medication-induced psoriasis - Those who have skin conditions other than psoriasis including eczema at the time of the screening that would interfere with evaluations of the study drug. |
| Country | Name | City | State |
|---|---|---|---|
| China | Site 07 | Changchun | |
| China | Site 13 | Changchun | |
| China | Site 14 | Chongqing | |
| China | Site 09 | Hangzhou | |
| China | Site 17 | Hangzhou | |
| China | Site 24 | Hangzhou | |
| China | Site 25 | Nanjing | |
| China | Site 01 | Peking | |
| China | Site 03 | Peking | |
| China | Site 04 | Peking | |
| China | Site 10 | Peking | |
| China | Site 11 | Peking | |
| China | Site 12 | Peking | |
| China | Site 21 | Peking | |
| China | Site 02 | Shanghai | |
| China | Site 05 | Shanghai | |
| China | Site 08 | Shanghai | |
| China | Site 06 | Tianjin | |
| China | Site 22 | Tianjin | |
| China | Site 23 | Urumqi | |
| China | Site 16 | Wenzhou | |
| China | Site 19 | Wuhan | |
| China | Site 20 | Wuhan | |
| China | Site 15 | Xi'an | |
| China | Site 18 | Xi'an |
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Kirin Co., Ltd. | Kyowa Hakko Kirin China Pharmaceutical Co., LTD. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of patients with treatment-emergent adverse events (TEAEs) or drug-related TEAEs | after received an investigational product until last visit 1 year | ||
| Primary | To evaluate the proportion of subjects achieving 75% improvement from baseline in Psoriasis Area and Severity Index (PASI; PASI 75) at Week 12 | Week 12 | ||
| Secondary | To evaluate the proportion of subjects achieving 100% improvement from baseline in PASI (PASI 100) at Week 12 | Week 12 | ||
| Secondary | To evaluate static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)" at Week 12 | Week 12 |
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