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

Incyte

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle Cream BID; Drug: Ruxolitinib 1.5% Cream QD; Drug: Ruxolitinib 0.15% Cream QD; Drug: Ruxolitinib 1.5% Cream BID; Drug: Ruxolitinib 0.5% Cream QD; Drug: Triamcinolone 0.1% Cream BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT03011892

INCB 18424-206

Details and patient eligibility

About

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Enrollment: 307 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Participants with evidence of active acute or chronic infections.

• Use of topical treatments for AD (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).

• Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).

• Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.

• Participants 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.

• Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:

  • Serum creatinine > 1.5 mg/dL.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.

• Participants 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).

• Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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307 participants in 12 patient groups, including a placebo group

Double Blind (DB): Vehicle BID

Placebo Comparator group

Description:

Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.

Treatment:

Drug: Vehicle Cream BID

DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID

Active Comparator group

Description:

Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.

Treatment:

Drug: Vehicle Cream BID

Drug: Triamcinolone 0.1% Cream BID

DB: Ruxolitinib 0.15% Once Daily (QD)

Experimental group

Description:

Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.

Treatment:

Drug: Ruxolitinib 0.15% Cream QD

DB: Ruxolitinib 0.5% QD

Experimental group

Description:

Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.

Treatment:

Drug: Ruxolitinib 0.5% Cream QD

DB: Ruxolitinib 1.5% QD

Experimental group

Description:

Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.

Treatment:

Drug: Ruxolitinib 1.5% Cream QD

DB: Ruxolitinib 1.5% BID

Experimental group

Description:

Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID

Placebo Comparator group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID

Active Comparator group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID

Experimental group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID

Experimental group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID

Experimental group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID

OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID

Experimental group

Description:

Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Treatment:

Drug: Ruxolitinib 1.5% Cream BID