trial overview
Evaluated in 2 identical
Phase 3 trials1,2
STUDIED FOR SHORT-TERM USE AND LONG-TERM FOR MANAGEMENT OF AD FLARE-UPS1,2
1249 adult and adolescent patients were included in 2 identically designed double-blind, randomized, vehicle-controlled trials.1,2
In both studies, patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks.1
key inclusion criteria1,3:
- Affected BSA of 3% to 20%
- ≥12 years of age
- IGA score of 2 or 3*
- Diagnosis of AD ≥2 years
| TRIAL ENDPOINTS INCLUDED KEY OUTCOMES IN AD1,3 | |
| Primary endpoint | |
| Skin clearance | |
| IGA-TS | Proportion of patients who achieved clear (IGA 0) or almost clear (IGA 1) skin with at least a 2-point improvement from baseline |
| Key secondary endpoints | |
| Itch relief | |
| Itch NRS4 | Proportion of patients with a ≥4-point improvement in itch on a 0- to 10-point scale |
| Reduction in lesion extent and severity | |
| EASI-75 | Proportion of patients who achieved ≥75% improvement from baseline in their EASI score |
| Other secondary endpoints | |
| EASI percent change from baseline | Mean percent change in lesion extent and severity (EASI) score |
| Itch NRS change from baseline | Mean change in self-reported Itch |
*Severity scale of 0 to 4.1
AD, atopic dermatitis; BID, twice daily; BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; IGA-TS, Investigator’s Global Assessment treatment success; NRS, numerical rating scale.
In the clinical trials, which included patients ≥12 years of age1,3:
- Affected BSA was 3% to 20% (mean ≈10%)1,3
- 39% of patients had facial involvement at baseline1
- 75% of the patients had an IGA score of 3 (moderate)1
BSA, body surface area; IGA, Investigator's Global Assessment.
BASELINE PATIENT CHARACTERISTICS1
| Study Participants (N = 1249) | |
|---|---|
| Age, y | |
| 12-17 | 20% |
| 19-64 | 71% |
| ≥65 | 9% |
| Race | |
| White | 70% |
| Black | 23% |
| Asian | 4% |
| Other | 3% |
| Lession appearance (IGA*) | |
| Score of 2 | 25% |
| Score of 3 | 75% |
| BSA % | |
| Mean | ≈10% |
| Worst Itch Intensity (Itch NRS†) | |
| Mean score | 5 |
*Patients had a baseline IGA score of 2 to 3 on a severity scale of 0 to 4.1
†Itch NRS is defined as a 7-day average of the worst level of itch intensity in the last 24 hours, measured on a scale of 0 to 10.
Patients in the analysis had an NRS score ≥4 at baseline.1,3
BSA, body surface area; IGA, Investigator's Global Assessment; NRS, numerical rating scale; y, years.
- Patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen2
- Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or OPZELURA2
- Patients self-evaluated active AD lesions and treated as needed (up to 20% BSA)2
- Patients were instructed to stop treatment 3 days after lesion clearance and restart treatment at the first sign of recurrence2
- If new lesions were extensive or appeared in new areas, patients were instructed to contact the investigator to determine if an unscheduled additional visit was needed. Rescue treatment was not permitted2
- Patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen2
- Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or OPZELURA2
- Patients self-evaluated active AD lesions and treated as needed (up to 20% BSA)2
- Patients were instructed to stop treatment 3 days after lesion clearance and restart treatment at the first sign of recurrence2
- If new lesions were extensive or appeared in new areas, patients were instructed to contact the investigator to determine if an unscheduled additional visit was needed. Rescue treatment was not permitted2
The graphic above shows the study design for OPZELURA, which was studied in 2 identically designed, double-blind, randomized, vehicle-controlled trials (TRuE-AD1 and TRuE-AD2). The 2 studies included 1249 adult and pediatric patients ≥12 years of age with an affected BSA of 3% to 20% and an IGA score of 2 to 3 on a severity scale of 0 to 4. Patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks.1
In a 44-week extension study, patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen. Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or OPZELURA. Patients self-evaluated active AD lesions and treated as needed BID (up to 20% BSA). Study visits in the extension period occurred every 4 weeks.2
AD, atopic dermatitis; BID, twice daily.
| PATIENT DISPOSITION IN THE EXTENSION PERIOD2 | ||
|---|---|---|
| TRuE-AD1 | TRuE-AD2 | |
| Patients entering extension period | 542 | 530 |
| Completed the study | 430(79.3%) | 401(75.7%) |
| Discontinued | 112(20.7%) | 129(24.3%) |
| Withdrew | 49(9.0%) | 78(14.7%) |
| Lost to follow-up | 41(7.6%) | 25(4.7%) |
| Discontinued (other) | 22(4.1%) | 26(4.9%) |
Safety and tolerability assessments included the frequency of reported TEAEs, treatment-related AEs, and AEs leading to discontinuation2
Disease control assessed by2:
- Proportion of patients with clear (IGA 0) or almost clear (IGA 1) skin
- Mean total affected BSA
AD, atopic dermatitis; AE, adverse event; BID, twice daily; BSA, body surface area; IGA, Investigator’s Global Assessment; TEAE, treatment-emergent adverse event.
