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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: ZPL389 30mg; Drug: ZPL389 50mg; Drug: TCS and/or TCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT03948334

CZPL389A2203E1

2018-000595-15 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

Subjects who had received ZPL389 30 mg or 50 mg doses in the core study (CZPL389A2203), continued to receive the same doses in double-blinded fashion. Subjects who had received ZPL389 3 mg, 10 mg or placebo in the core study were randomized to 30 mg or 50 mg ZPL389 in a 1:1 ratio. All subjects received concomitant or intermittent TCS and/or TCI along with ZPL389. Short-term safety was assessed up to week 16 of this extension study (week 16 to week 32 referring to the start of core study treatment) and long-term safety was assessed after week 16 of this extension study (after week 32 referring to the start of core study treatment). The entire planned time frame (100 weeks) was not assessed as originally planned due to early termination of the core and extension studies.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must give a written, signed and dated informed consent
• Subjects with atopic dermatitis who have participated in and completed 16 weeks of treatment in CZPL389A2203 study.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, diary completion and other study procedures.

Exclusion criteria

• Inability to use TCS and/or TCI due to history of important side effects of topical medication (e.g., intolerance or hypersensitivity reactions).
• Treatment discontinued subject from CZPL389A2203 study.
• Any skin disease that would confound the diagnosis or evaluation of atopic dermatitis disease activity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups

ZPL389 30mg

Experimental group

Description:

30mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study

Treatment:

Drug: TCS and/or TCI

Drug: ZPL389 30mg

ZPL389 50mg

Experimental group

Description:

50mg of ZPL389 + TCS and/or TCI for patients re-randomized from the core study (received placebo/ZPL389 3mg/ 10mg in the core study) and for patients continuing in the same arm from the core study

Treatment:

Drug: ZPL389 50mg

Drug: TCS and/or TCI