A Phase 3 interventional study of Core Treatment Active Experimental: SHR0302 Dose#1 and Core Treatment Active Experimental: SHR0302 Dose#2 in Atopic Dermatitis, sponsored by Reistone Biopharma Company Limited. Completed at 52 sites in 2 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Reistone Biopharma Company Limited · Phase 3, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 336 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Reistone Biopharma Company Limited is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: Core Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
Drug: Core Treatment Active Experimental: SHR0302 Dose#2
Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
Drug: Core Treatment Placebo Comparator: Placebo
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Drug: Extension Treatment Active Experimental: SHR0302 Dose#1
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Drug: Extension Treatment Active Experimental: SHR0302 Dose#2
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
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Drug: SHR0302 Oral tablets taken once daily (QD) for 36 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.
Time frame: Week 1, 4, 8 and 12
NRS-4 at Week 24, 32, 40, 52 and 56
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during extension treatment phase.
Time frame: All scheduled visits from Week 24 - 56
EASI 75 at Week 24, 32, 40, 52 and 56
Proportion of subjects achieving EASI 75 at all scheduled visits during extension treatment phase.
Time frame: All scheduled visits from Week 16 24 - 56
IGA 0/1 at Week 24, 32, 40, 52 and 56
Proportion of subjects achieving IGA0/1 and a reduction from baseline of ≥2 points at all scheduled visits during extension treatment phase.
Time frame: All scheduled visits from Week 24 - 56
EASI 50 and EASI 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Proportion of subjects with ≥50% EASI improvement from baseline (EASI 50) at all scheduled visits.
Time frame: Day 1 to Week 56
Change of EASI from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in the eczema area and severity index (EASI) total score at all scheduled visits. The EASI score ranges from 0.0 to 72.0, can be varied in increments of 0.1, Higher scores indicate greater severity.
Time frame: Day 1 to Week 56
SCORAD 50, SCORAD 75 and SCORAD 90 at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
SCORing Atopic Dermatitis (SCORAD). Score of 0-103. Higher scores mean more severe. Proportion of subjects achieving a ≥50%, 75% and 90% improvement in SCORAD (SCORAD 50, SCORAD 75 and SCORAD 90) from baseline at all scheduled visits.
Time frame: Day 1 to Week 56
Change of SCORAD from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in SCORAD at all scheduled visits
Time frame: Day 1 to Week 56
Change of BSA from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in body surface area (BSA) affected at all scheduled visits
Time frame: Day 1 to Week 56
Change of IgE from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in the level of serum IgE in peripheral blood at all scheduled visits.
Time frame: Day 1 to Week 56
Change of eosinophils from baseline at Week 1, 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in the level of serum eosinophils in peripheral blood at all scheduled visits.
Time frame: Day 1 to Week 56
Change of dermatology life quality index (DLQI) or Children's DLQI (CDLQI) PROs from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in dermatology life quality index (DLQI) or Children's DLQI (CDLQI) score at all scheduled visits. The DLQI CDLQI consists of questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. This is not a scale. There are no minimum or maximum values. The quality index just captures a subjects perception of the impact of skin disease on different aspects of their health-related quality of life over the last week.
Time frame: Day 1 to Week 56
Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 4, 8, 12, 16, 24, 32, 40, 52 and 56
Change from baseline in Patient-Oriented Eczema Measure (POEM) at all scheduled visits. 7-item, patient-administered scale that assesses disease severity in children and adults. Subjects respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0-28 with higher total scores indicating greater disease severity.
Time frame: Day 1 to Week 56
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Reistone Biopharma Company Limited