This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.
This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
336
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Time frame: 16 Weeks
Eczema Area and Severity Index (EASI 75) at Week 16
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.
Time frame: 16 Weeks
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
Time frame: Week 16
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16.
Time frame: Week 1, 4, 8 and 12
Time to WI-NRS response
Time from baseline to achieve at least 4 points improvement of WI-NRS during placebo-controlled treatment phase.
Time frame: Baseline to Week 16
EASI 75 at Week 1, 4, 8 and 12
Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16.
Time frame: Week 1, 4, 8 and 12
IGA 0/1 at Week 1, 4, 8 and 12
Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during placebo-controlled treatment phase except Week 16.
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Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
Dr Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research
Winnipeg, Manitoba, Canada
CCA Medical Research
Ajax, Ontario, Canada
SKiN Health
Cobourg, Ontario, Canada
DermEffects
London, Ontario, Canada
North York Research Inc.
North York, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
York Dermatology
Richmond Hill, Ontario, Canada
...and 42 more locations
Time frame: Week 1, 4, 8 and 12