Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis | Biological: SCT630 Biological: Adalimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Double-blind Study Evaluating the Efficacy and Safety of SCT630 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis |
Actual Study Start Date : | September 5, 2019 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: SCT630
Participants received 80 mg SCT630 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg SCT630 until week 48. |
Biological: SCT630
Administered by subcutaneous injection
|
Active Comparator: adalimumab-EU source
Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to SCT630 until week 48 |
Biological: Adalimumab
Administered by subcutaneous injection
|
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Shaanxi | |
First Affiliated Hospital of Fourth Military Medical University | |
Xi'an, Shaanxi, China |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 22, 2019 | ||||
First Posted Date ICMJE | April 25, 2019 | ||||
Last Update Posted Date | January 29, 2021 | ||||
Actual Study Start Date ICMJE | September 5, 2019 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline and Week 16 ] The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis | ||||
Official Title ICMJE | A Phase 3, Randomized, Double-blind Study Evaluating the Efficacy and Safety of SCT630 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis | ||||
Brief Summary | The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||||
Condition ICMJE | Psoriasis | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
330 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03927352 | ||||
Other Study ID Numbers ICMJE | SCT630PS03 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Sinocelltech Ltd. | ||||
Study Sponsor ICMJE | Sinocelltech Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sinocelltech Ltd. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |