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Trial record 8 of 124 for:    INCB018424

A Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03011892
First received: January 3, 2017
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
The purpose of this study is to establish the efficacy of each strength of INCB018424 cream once daily (QD) or twice daily (BID) in subjects with atopic dermatitis as compared with vehicle cream BID.

Condition Intervention Phase
Atopic Dermatitis
Drug: INCB018424 cream
Drug: Triamcinolone 0.1% cream
Drug: Vehicle cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score at Week 4 in subjects treated with 1.5% INCB018424 BID compared with subjects treated with vehicle cream BID [ Time Frame: From baseline to Week 4 ]

Secondary Outcome Measures:
  • Mean percentage change from baseline in EASI score at Week 4 in subjects treated with INCB018424 compared with subjects treated with vehicle cream BID [ Time Frame: From baseline to Week 4 ]
  • Mean percentage change from baseline in EASI score at Week 4 in subjects treated with INCB018424 compared with subjects treated with triamcinolone 0.1% cream BID [ Time Frame: From baseline to Week 4 ]
  • Proportion of subjects achieving an Investigator's Global Assessment (IGA) score of 0 to 1 who have an improvement of ≥ 2 points from baseline at Week 4 [ Time Frame: From baseline to Week 4 ]
  • Mean change from baseline in the Itch Numerical Rating Scale (NRS) score at Week 4 [ Time Frame: From baseline to Week 4 ]
  • Safety and tolerability assessed by monitoring the frequency, duration, and severity of adverse events (AEs) [ Time Frame: From baseline to 1 month after end of treatment, up to 16 weeks ]

Estimated Enrollment: 300
Study Start Date: December 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB018424 cream 1.5% BID
INCB018424 cream 1.5% applied BID for 8 weeks. At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.
Drug: INCB018424 cream
INCB018424 1.5% cream
Experimental: INCB018424 cream 1.5% QD
INCB018424 cream 1.5% applied QD for 8 weeks. At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.
Drug: INCB018424 cream
INCB018424 1.5% cream
Experimental: INCB018424 cream 0.5% QD
INCB018424 cream 0.5% applied QD for 8 weeks. At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.
Drug: INCB018424 cream
INCB018424 0.5% cream
Experimental: INCB018424 cream 0.15% QD
INCB018424 cream 0.15% applied QD for 8 weeks. At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.
Drug: INCB018424 cream
INCB018424 0.15% cream.
Active Comparator: Triamcinolone 0.1% cream BID

Vehicle cream applied BID for 4 weeks after triamcinolone 0.1% cream applied BID for initial 4 weeks.

At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.

Drug: Triamcinolone 0.1% cream
Triamcinolone 0.1% cream BID
Drug: Vehicle cream
Placebo Comparator: Vehicle cream
Vehicle cream applied BID for 8 weeks. At Week 8, subjects who meet criteria will be offered open-label treatment with INCB018424 1.5% cream BID for 4 weeks.
Drug: Vehicle cream

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.
  • Subjects with a history of atopic dermatitis for at least 2 years.
  • Subjects with an Investigator's Global Assessment score of 2 to 3 at screening and baseline.
  • Subjects with body surface area of atopic dermatitis involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
  • Subjects who agree to discontinue all agents used to treat atopic dermatitis from screening through the final follow-up visit.

Exclusion Criteria:

  • Subjects with evidence of active acute or chronic infections.
  • Use of topical treatments for atopic dermatitis (other than bland emollients) within 2 weeks of baseline.
  • Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
  • Subjects with other dermatologic disease besides atopic dermatitis whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
  • Subjects with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.
  • Subjects with cytopenias at screening, defined as:

    • Leukocytes < 3.0 × 10^9/L.
    • Neutrophils < lower limit of normal.
    • Hemoglobin < 10 g/dL.
    • Lymphocytes < 0.8 × 10^9/L
    • Platelets < 100 × 10^9/L.
  • Subjects with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease on dialysis or at least 1 of the following:

    • Serum creatinine > 1.5 mg/dL.
    • Alanine aminotransferase or aspartate aminotransferase ≥ 1.5 × upper limit of normal.
  • Subjects taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
  • Subjects who have previously received Janus kinase inhibitors, systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03011892

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, North Carolina
Recruiting
High Point, North Carolina, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Michael Kuligowski, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03011892     History of Changes
Other Study ID Numbers: INCB 18424-206 
Study First Received: January 3, 2017
Last Updated: January 5, 2017

Keywords provided by Incyte Corporation:
Atopic dermatitis
eczema
pruritus
Janus kinase (JAK) inhibitors

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 20, 2017