Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Pruritus in Patients With Atopic Dermatitis

Treatments: Drug: Placebo to 5 mg; Drug: Placebo to 1mg; Drug: Placebo to 100 mg; Drug: DNK333 100 mg; Drug: Placebo to 25 mg; Drug: DNK333 25 mg; Drug: DNK333 5 mg; Drug: DNK333 1mg; Drug: Betamethasone 4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033097

CDNK333B2103

EudraCT 2009-012098-36 (Other Identifier)

Details and patient eligibility

About

This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
• Requirement of systemic therapy
• Itch VAS score higher than 50 mm
• EASI score higher than 8

Exclusion criteria

• Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
• Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
• Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 9 patient groups, including a placebo group

DNK333 5 mg

Experimental group

Treatment:

Drug: DNK333 5 mg

Placebo to DNK333 5mg

Placebo Comparator group

Treatment:

Drug: Placebo to 5 mg

DNK333 25 mg

Experimental group

Treatment:

Drug: DNK333 25 mg

Placebo to DNK333 25 mg

Placebo Comparator group

Treatment:

Drug: Placebo to 25 mg

DNK333 100 mg

Experimental group

Treatment:

Drug: DNK333 100 mg

Placebo to DNK333 100 mg

Placebo Comparator group

Treatment:

Drug: Placebo to 100 mg

Betamethasone 4 mg

Active Comparator group

Treatment:

Drug: Betamethasone 4 mg

DNK333 1 mg

Experimental group

Treatment:

Drug: DNK333 1mg

placebo 1mg

Placebo Comparator group

Treatment:

Drug: Placebo to 1mg