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.

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Delgocitinib cream; Drug: Delgocitinib cream vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03725722

LP0133-1275

Details and patient eligibility

About

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).

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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251 participants in 5 patient groups, including a placebo group

Delgocitinib cream 1 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 8 weeks

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 3 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 8 weeks

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 8 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 8 weeks

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 20 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 8 weeks

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream vehicle

Placebo Comparator group

Description:

Delgocitinib cream vehicle applied twice daily for 8 weeks

Treatment:

Drug: Delgocitinib cream vehicle