Overview

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

Status:
Not yet recruiting
Trial end date:
2023-11-05
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Corporation
Criteria
Inclusion Criteria:

- Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3
months or ≥ 2 flares within the previous 12 months.

- Screening and baseline IGA-CHE 3 or 4.

- Baseline CHE-related Itch NRS ≥ 4.

- Recent history (within the past 1 year of baseline) of inadequate response to
treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or
oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral
alitretinoin.

- Willingness to avoid pregnancy or fathering children based on the criteria below.

Exclusion Criteria:

- Known triggers for CHE (allergic or irritant, such as those identified by previous
patch tests) cannot be avoided during the course of this study.

- Participants who have an unstable course of AD (spontaneously improving or rapidly
deteriorating) as determined by the investigator in the 4 weeks prior to baseline.

- Participants with concurrent conditions and history of other diseases such as other
active skin disease or infection on the hands; immunocompromised; chronic or acute
infection requiring systemic treatments; active acute skin infection; other
concomitant skin conditions that may interfere with study assessments or compromise
participant safety; other types of eczema; chronic asthma requiring high dose of
inhaled corticosteroids; current or history of hepatitis B or C virus infection.

- Any serious illness or medical, physical, or psychiatric condition(s) that, in the
investigator's opinion, would interfere with full participation in the study,
including administration of study drug and attending required study visits; pose a
significant risk to the participant; or interfere with interpretation of study data.

- Laboratory values outside of the protocol-defined criteria.

- Use of protocol-defined treatments within the indicated washout period before
baseline.

- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4
weeks before baseline.

- Pregnant or lactating participants, or those considering pregnancy during the period
of their study participation.

- Further exclusion criteria apply.