A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis

• ClinicalTrials.gov Identifier: NCT00820950
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Last Update Posted: March 26, 2019
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

Brief Summary:

The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Ruxolitinib phosphate cream; Drug: Dovonex® calcipotriene 0.005%; Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Drug: Placebo cream	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Vehicle-Controlled, Rising Dose, Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis
• Study Start Date: May 2007
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: April 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment 1: Ruxolitinib; Ruxolitinib -- 0.5%	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 0.5%; Other Name: INCB018424
Experimental: Treatment 2: Ruxolitinib; Ruxolitinib -- 1.0%	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.0%; Other Name: INCB018424
Experimental: Treatment 3: Ruxolitinib; Ruxolitinib -- 1.5%	Drug: Ruxolitinib phosphate cream; Ruxolitinib phosphate cream 1.5%; Other Name: INCB018424
Placebo Comparator: Treatment 4: Placebo; Placebo Cream	Drug: Placebo cream; Cream applied once or twice daily for 56 days
Active Comparator: Treatment 5: Dovonex® calcipotriene; Dovonex® calcipotriene 0.005% cream	Drug: Dovonex® calcipotriene 0.005%; Cream applied once or twice daily for up to 56 days.
Active Comparator: Treatment 6: Diprolene® AF betamethasone diproprionate	Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.; Cream applied once or twice daily for up to 56 days

Outcome Measures

Primary Outcome Measures :

1. Efficacy of ruxolitinib, 0.5%, 1.0%, and 1.5% cream formulation applied once or twice daily compared with vehicle, Dovonex® calcipotriene 0.005% cream or Diprolene® AF betamethasone dipropionate 0.05% cream. [ Time Frame: Baseline, Week 1, 2, 3, 4 and 8 (or early study termination visit) ]

   Efficacy endpoints will include:

   Efficacy Endpoint

   1. Change in target lesion scores (erythema, E; scaling, S; and thickness, T) including total score (E+S+T) and each component analyzed separately.
   2. Change in target lesion area

Secondary Outcome Measures :

1. Characterize the safety of ruxolitinib 0.5%, 1.0% and 1.5% cream formulations when applied once or twice daily by monitoring the frequency, duration and severity of adverse and serious adverse events [ Time Frame: Baseline, Week 1, 2, 3, 4 and 8 (or early study termination visit). In addition, safety will also be assessed through the spontaneous reporting of serious adverse events ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) of 17 to 40 kg/m2
• Subjects must have two comparable psoriatic lesions measuring between 9 and 100 cm2 and these target lesions must be similar in size to each other, and separated by at least 15 cm.

Exclusion Criteria:

• Subjects with lesions solely involving the palms of the hands or soles of the feet or intertriginous areas, the scalp or the face.
• Subjects with pustular psoriasis or erythroderma.
• Subjects currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication.
• Subjects receiving PUVA within 4 weeks of the first dose of study medication.
• Subjects receiving systemic retinoids, etanercept, adalimumab or efalizumab or oral immunosuppressives within 3 months prior to the first dose of study medication.
• Subjects receiving any other biological therapy (infliximab, alefacept, abatacept, etc) within 3 months of the first dose of study medication.

Contacts and Locations

Locations

United States, California

Vallejo, California, United States

United States, Massachusetts

Boston, Massachusetts, United States

United States, New York

Rochester, New York, United States

Stony Brook, New York, United States

United States, Oregon

Portland, Oregon, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

Incyte Corporation

Investigators

• Study Director: William Williams, MD; Incyte Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Punwani N, Scherle P, Flores R, Shi J, Liang J, Yeleswaram S, Levy R, Williams W, Gottlieb A. Preliminary clinical activity of a topical JAK1/2 inhibitor in the treatment of psoriasis. J Am Acad Dermatol. 2012 Oct;67(4):658-64. doi: 10.1016/j.jaad.2011.12.018. Epub 2012 Jan 24.

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT00820950
• Other Study ID Numbers: INCB 18424-201
• First Posted: January 12, 2009
• Last Update Posted: March 26, 2019
• Last Verified: March 2019

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents