Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

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Novartis

Status and phase

Completed
Phase 2

Conditions

Pruritus in Patients With Atopic Dermatitis

Treatments

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

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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