Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Chronic Hand Eczema

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03683719

LP0133-1273

Details and patient eligibility

About

The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.

Enrollment: 258 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Age 18 years or above.
• Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
• Disease severity graded as mild to severe according to IGA (i.e., IGA ≥2).
• Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
• Diagnostic patch testing performed within 3 years prior to the screening visit.

Key Exclusion Criteria:

• Concurrent skin diseases on the hands e.g tinnea manuum.
• Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
• Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
• Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
• Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
• Receipt of live attenuated vaccines 4 weeks prior to baseline.
• Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 (PDE-4) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
• Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
• Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
• Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 1 week prior to baseline.
• Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 1 week prior to baseline.
• Receipt of any marketed or investigational biologic agents within 6 months or 5 half-lives prior to baseline or until cells count returns to normal, whichever is longer.
• Clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to baseline.
• Tuberculosis requiring treatment within 12 months prior to screening and/or subjects with a positive blood test for tuberculosis at screening.
• History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the subject taking antiretroviral medications.
• Any disorder which is not stable and in the investigator's opinion could affect the safety of the subject, influence the findings of the trial, or impede the subject's ability to complete the trial.
• Positive hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), or hepatitis C virus antibody (anti-HCV) serology at screening. Subjects with positive HBsAb may be randomised provided they are hepatitis B vaccinated and have negative HBsAg and HBcAb.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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258 participants in 5 patient groups, including a placebo group

Delgocitinib cream 1 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 16 weeks.

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 3 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 16 weeks.

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 8 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 16 weeks.

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream 20 mg/g

Experimental group

Description:

Delgocitinib cream applied twice daily for 16 weeks.

Treatment:

Drug: Delgocitinib cream

Delgocitinib cream vehicle

Placebo Comparator group

Description:

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Treatment:

Drug: Delgocitinib cream vehicle