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

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

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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