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A Study to Assess the Safety and Efficacy of ZPL389 With TCS/TCI in Atopic Dermatitis Patients

NCT03948334 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2021-10-08

Study results available
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Summary

This extension study (CZPL389A2203E1) was designed as a 2-year (100 weeks) extension to the core study (CZPL389A2203/ NCT03517566) which is disclosed separately. It aimed to assess the short-term and long-term safety of (blinded) 30 mg o.d and 50 mg o.d ZPL389 with concomitant or intermittent use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI).

Conditions

Interventions

DRUG

ZPL389 30mg

30mg of ZPL389; once daily

DRUG

ZPL389 50mg

50mg of ZPL389; once daily

DRUG

TCS and/or TCI

Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2020-07-23
Completion
2020-08-25
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

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 NCT03948334 on ClinicalTrials.gov