NCT00778700

A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Completed Phase 2 Results posted Last updated 9 February 2022

What this trial tests

Phase 2 trial testing Placebo Cream in Psoriasis in 199 participants. Completed in 26 June 2009.

Timeline

28 October 2008

Primary endpoint
26 June 2009

26 June 2009

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	199
Start date	28 October 2008
Primary completion	26 June 2009
Estimated completion	26 June 2009
Sites	28 locations across United States

Drugs / interventions tested

• Placebo Cream
• Ruxolitinib Phosphate — full drug profile →

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Incyte Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84 Primary · From Baseline (Day 1) to Day 84

Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.

Group	Value	95% CI
Vehicle Cream	-1.07	± 0.290
Ruxolitinib Phosphate 0.5% Cream	-2.25	± 0.284
Ruxolitinib Phosphate 1.0% Cream	-2.47	± 0.285
Ruxolitinib Phosphate 1.5% Cream	-2.27	± 0.287

Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness Secondary · From Baseline (Day 1) to Day 84

Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.

Group	Value	95% CI
Vehicle Cream	-0.45	± 0.775
Ruxolitinib Phosphate 0.5% Cream	-0.71	± 0.677
Ruxolitinib Phosphate 1.0% Cream	0.84	± 0.898
Ruxolitinib Phosphate 1.5% Cream	-0.90	± 0.778

Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema Secondary · From Baseline (Day 1) to Day 84

Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.

Group	Value	95% CI
Vehicle Cream	-0.45	± 0.711
Ruxolitinib Phosphate 0.5% Cream	-0.59	± 0.757
Ruxolitinib Phosphate 1.0% Cream	-0.72	± 0.889
Ruxolitinib Phosphate 1.5% Cream	-0.64	± 0.872

Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling Secondary · From Baseline (Day 1) to Day 84

Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.

Group	Value	95% CI
Vehicle Cream	-0.46	± 0.972
Ruxolitinib Phosphate 0.5% Cream	-0.91	± 0.741
Ruxolitinib Phosphate 1.0% Cream	-0.87	± 0.991
Ruxolitinib Phosphate 1.5% Cream	-0.85	± 0.961

Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness Secondary · From Baseline (Day 1) to Day 84

Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.

Group	Value	95% CI
Vehicle Cream	-17.37	± 31.075
Ruxolitinib Phosphate 0.5% Cream	-30.95	± 27.851
Ruxolitinib Phosphate 1.0% Cream	-36.56	± 38.447
Ruxolitinib Phosphate 1.5% Cream	-36.80	± 33.016

Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema Secondary · From Baseline (Day 1) to Day 84

Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.

Group	Value	95% CI
Vehicle Cream	-15.40	± 22.146
Ruxolitinib Phosphate 0.5% Cream	-22.53	± 27.702
Ruxolitinib Phosphate 1.0% Cream	-30.74	± 39.404
Ruxolitinib Phosphate 1.5% Cream	-23.93	± 35.828

Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling Secondary · From Baseline (Day 1) to Day 84

Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.

Group	Value	95% CI
Vehicle Cream	-17.68	± 38.175
Ruxolitinib Phosphate 0.5% Cream	-37.13	± 28.050
Ruxolitinib Phosphate 1.0% Cream	-35.38	± 44.140
Ruxolitinib Phosphate 1.5% Cream	-36.11	± 41.286

Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84 Secondary · Day 84

Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure.

Group	Value	95% CI
Vehicle Cream	25.5
Ruxolitinib Phosphate 0.5% Cream	55.1
Ruxolitinib Phosphate 1.0% Cream	55.1
Ruxolitinib Phosphate 1.5% Cream	50.0

Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84 Secondary · Day 84

The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.

Group	Value	95% CI
Vehicle Cream	19.1
Ruxolitinib Phosphate 0.5% Cream	34.7
Ruxolitinib Phosphate 1.0% Cream	46.9
Ruxolitinib Phosphate 1.5% Cream	33.3

Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84 Secondary · Day 84

The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.

Group	Value	95% CI
Vehicle Cream	42.6
Ruxolitinib Phosphate 0.5% Cream	61.2
Ruxolitinib Phosphate 1.0% Cream	63.3
Ruxolitinib Phosphate 1.5% Cream	50.0

Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA) Secondary · Baseline (Day 1) to Day 84

The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m\^²)=(\[Height(cm) x Weight(kg)\]/3600 )\^½. A negative change from Baseline indicates improvement.

Group	Value	95% CI
Vehicle Cream	-0.36	± 2.260
Ruxolitinib Phosphate 0.5% Cream	-1.63	± 3.746
Ruxolitinib Phosphate 1.0% Cream	-2.41	± 4.276
Ruxolitinib Phosphate 1.5% Cream	-1.94	± 3.545

Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score Secondary · Baseline (Day 1) to Day 84

The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses.

Group	Value	95% CI
Vehicle Cream	-0.34	± 0.760
Ruxolitinib Phosphate 0.5% Cream	-0.73	± 0.836
Ruxolitinib Phosphate 1.0% Cream	-0.92	± 1.077
Ruxolitinib Phosphate 1.5% Cream	-0.79	± 0.922

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose up to 28 days after last dose of study drug (Up to 16 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vehicle Cream

Serious: 1/50 (2%)

Deaths: 0/50

Ruxolitinib Phosphate 0.5% Cream

Serious: 2/51 (4%)

Deaths: 0/51

Ruxolitinib Phosphate 1.0% Cream

Serious: 0/49 (0%)

Deaths: 0/49

Ruxolitinib Phosphate 1.5% Cream

Serious: 3/49 (6%)

Deaths: 0/49

Total

Serious: 6/199 (3%)

Deaths: 0/199

Serious adverse events (7 terms)

Reaction	System	Vehicle Cream	Ruxolitinib Phosphate 0.5%…	Ruxolitinib Phosphate 1.0%…	Ruxolitinib Phosphate 1.5%…	Total
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—
Coronary artery occlusion	Cardiac disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Vehicle Cream	Ruxolitinib Phosphate 0.5%…	Ruxolitinib Phosphate 1.0%…	Ruxolitinib Phosphate 1.5%…	Total
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Application site irritation	General disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Application site pruritus	General disorders	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Electrocardiogram QT interval abnormal	Investigations	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—

Most-reported serious reactions: Cerebrovascular accident, Cholelithiasis, Coronary artery occlusion, Gastrooesophageal reflux disease, Intervertebral disc protrusion, Procedural pain, Prostate cancer.

Data from ClinicalTrials.gov NCT00778700 adverse events section.

Sponsor's own description

The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
   Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
2. Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
   Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862
3. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
   Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
4. The arrival of JAK inhibitors: advancing the treatment of immune and hematologic disorders.
   Furumoto Y, Gadina M. · · 2013 · cited 73× · PMID 23743669 · DOI 10.1007/s40259-013-0040-7
5. The new entries in the therapeutic armamentarium: The small molecule JAK inhibitors.
   Bechman K, Yates M, Galloway JB. · · 2019 · cited 64× · PMID 31401212 · DOI 10.1016/j.phrs.2019.104392
6. Interplay between Humoral and CLA⁺ T Cell Response against <i>Candida albicans</i> in Psoriasis.
   de Jesús-Gil C, Sans-de San Nicolàs L, Ruiz-Romeu E, Ferran M, et al · · 2021 · cited 15× · PMID 33546306 · DOI 10.3390/ijms22041519
7. Repurposing approved therapeutics for new indication: Addressing unmet needs in psoriasis treatment.
   Jain H, Bhat AR, Dalvi H, Godugu C, et al · · 2021 · cited 13× · PMID 34909670 · DOI 10.1016/j.crphar.2021.100041
8. Therapeutic Advances in Psoriasis: From Biologics to Emerging Oral Small Molecules.
   Ferrara F, Verduci C, Laconi E, Mangione A, et al · · 2024 · cited 9× · PMID 39311381 · DOI 10.3390/antib13030076