ClinicalTrials.Veeva

Menu

A Study to Assess the Safety and Efficacy of ZPL389 in Patients With Moderate to Severe Atopic Dermatitis

Novartis logo

Novartis

Status and phase

Terminated
Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: ZPL389 30mg
Drug: ZPL389 3mg
Drug: ZPL389 50mg
Drug: ZPL389 10mg
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03517566
CZPL389A2203

Details and patient eligibility

About

This was a randomized, double-blind, placebo-controlled, parallel-group study to assess safety and efficacy of ZPL389 in subjects with moderate to severe atopic dermatitis with a total study duration up to 24 weeks

Full description

A screening period of up to 4 weeks was followed by a 16-week double blinded treatment period.

After the end of treatment visit, subjects were offered the possibility of ongoing treatment in the extension study (CZPL389A2203E1/ NCT03948334), or of entering the 4 week treatment-free follow-up period.

Enrollment

293 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must give a written, signed and dated informed consent
  • Chronic atopic dermatitis present for at least 1 year before Baseline
  • Moderate to severe atopic dermatitis defined as per EASI, IGA and BSA.
  • Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable
  • Candidate for systemic treatment

Exclusion criteria

  • Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity
  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  • History of hypersensitivity to any of the study drug constituents or to drugs of similar chemical classes.
  • Participation in prior ZPL389 studies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

293 participants in 5 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo
ZPL389 3mg
Experimental group
Description:
ZPL389 3 mg oral powder
Treatment:
Drug: ZPL389 3mg
ZPL389 10 mg
Experimental group
Description:
ZPL389 10 mg oral powder
Treatment:
Drug: ZPL389 10mg
ZPL389 30mg
Experimental group
Description:
ZPL389 30 mg oral powder
Treatment:
Drug: ZPL389 30mg
ZPL389 50mg
Experimental group
Description:
ZPL389 50 mg oral powder
Treatment:
Drug: ZPL389 50mg

Trial documents
2

Trial contacts and locations

89

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems