Phase 2
Completed N=251
Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
Source: ClinicalTrials.gov NCT03725722 ↗Enrolled (actual)
251
Serious AEs
1.2%
Results posted
Jul 2021
Primary outcomePrimary: Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score. — -5.0; -4.9; -5.8; -7.6 score on a scale — p=<0.0001
Summary
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group trial. The trial is designed to establish a dose-response signal and investigate the efficacy and safety of delgocitinib cream in the treatment of adult subjects with mild to severe atopic dermatitis (AD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) Score. |
-5.0; -4.9; -5.8; -7.6; -1.9 | <0.0001 sig |
| SECONDARY Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) Score of 0 (Clear) or 1 (Almost Clear) With ≥2-step Improvement (vIGA-AD TS) From Baseline to Week 8. |
9; 14; 15; 24; 5 | <0.0001 sig |
| SECONDARY EASI75 at Week 8 |
20; 21; 28; 33; 10 | <0.0001 sig |
| SECONDARY Time to vIGA-AD TS |
64; NA; 64; 44; NA | >0.05 |
Eligibility Criteria
Key Inclusion Criteria
- Age 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.
- History of AD for ≥1 year.
- AD involvement of 5-50% treatable body surface area at screening and at baseline (excluding scalp).
- Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD ≥2) at screening and baseline.
Key Exclusion Criteria
- AD lesion(s) on scalp at screening and/or baseline.
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea, urticaria, or psoriasis.
- Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of severity of AD.
- Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4 weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to baseline.
- Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.
- Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
- Receipt of live attenuated vaccines within 4 weeks prior to baseline.
- Treatment with any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline, or until cell counts return to normal, whichever is longer.
- History of any active skin infection within 1 week prior to baseline.
- Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
Data sourced from ClinicalTrials.gov (NCT03725722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.