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

NCT03517566 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2021-10-08

Study results available
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Summary

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

Conditions

Interventions

DRUG

Placebo

once daily from baseline until week 16

DRUG

ZPL389 3mg

ZPL389 3 mg oral powder; once daily from baseline to week 16

DRUG

ZPL389 10mg

ZPL389 10 mg oral powder; once daily from baseline to week 16

DRUG

ZPL389 30mg

ZPL389 30 mg oral powder; once daily from baseline to week 16

DRUG

ZPL389 50mg

ZPL389 50 mg oral powder; once daily from baseline to week 16

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2020-07-15
Completion
2020-08-06
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Iceland
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517566 on ClinicalTrials.gov