PsoriasisPhase 2NCT00820950

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

A Phase 2 study testing Ruxolitinib phosphate cream, Dovonex® calcipotriene 0.005% and Diprolene® AF betamethasone dipropionate 0.05% cream. in people with Psoriasis, run by Incyte Corporation at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis
What is being tested?: Ruxolitinib phosphate cream, Dovonex® calcipotriene 0.005% and Diprolene® AF betamethasone dipropionate 0.05% cream.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 6 sitesUnited States
Study dates: 31 May 2007to 30 Apr 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Boston, Massachusetts
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
Stony Brook, New York
Study site
Vallejo, California

Other trials in United States

About this study

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

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.

Conditions: Psoriasis
Being tested: Ruxolitinib phosphate cream, Dovonex® calcipotriene 0.005%, Diprolene® AF betamethasone dipropionate 0.05% cream., Placebo cream
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ruxolitinib phosphate creamDrug
Also called INCB018424
Ruxolitinib phosphate cream 0.5%
Dovonex® calcipotriene 0.005%Drug
Cream applied once or twice daily for up to 56 days.
Diprolene® AF betamethasone dipropionate 0.05% cream.Drug
Cream applied once or twice daily for up to 56 days
Placebo creamDrug
Cream applied once or twice daily for 56 days
Ruxolitinib phosphate creamDrug
Also called INCB018424
Ruxolitinib phosphate cream 1.0%
Ruxolitinib phosphate creamDrug
Also called INCB018424
Ruxolitinib phosphate cream 1.5%

Study groups in NCT00820950
Study group	Role	What they receive
Cohort A: INCB018424 Ruxolitinib 0.5%	Experimental	INCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days Receives: Drug: Ruxolitinib phosphate cream; Drug: Placebo cream
Cohort B: INCB018424 Ruxolitinib 1.0%	Experimental	INCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days Receives: Drug: Placebo cream; Drug: Ruxolitinib phosphate cream
Cohort C: INCB018424 Ruxolitinib 1.5%	Experimental	INCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days Receives: Drug: Placebo cream; Drug: Ruxolitinib phosphate cream
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene	Experimental	INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days Receives: Drug: Dovonex® calcipotriene 0.005%
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate	Experimental	INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days Receives: Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Measured: Baseline, Days 8, 15, 22, 28 and 56
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Measured: Baseline, Days 8, 15, 22, 28 and 56
Number of Participants With Treatment Emergent Adverse Events
A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Measured: 3 months
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Measured: Days 8, 15, 22, and 28
Pharmacokinetics Parameter : Bioavailability of INCB018424
The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.
Measured: Days 8, 15, 22, and 28

Secondary outcomes (1)

Change in Target Lesion Area Compared to Baseline
Lesion area was estimated on Day 1 and Day 28 using a tracings of the lesion on transparency paper and measurement of the area.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 200730 Apr 2009

First posted12 Jan 2009 (estimated)
Study start31 May 2007
Primary completion31 Jan 2009
Study completion30 Apr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00820950
Sponsor's protocol ID: INCB 18424-201
Status last verified: Feb 2022
First submitted: 8 Jan 2009
Last updated: 8 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22281165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00820950
Acronym / sponsor ID: INCB 18424-201
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 31 May 2007 (actual)
Primary completion: 31 Jan 2009 (actual)
Study completion: 30 Apr 2009 (actual)
First posted: 12 Jan 2009 (estimated)
Results: Posted 8 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Cohort A: INCB018424 Ruxolitinib 0.5%	Experimental	Drug: Ruxolitinib phosphate cream, Drug: Placebo creamINCB018424 Ruxolitinib 0.5% vs vehicle applied once daily for 28 days
Cohort B: INCB018424 Ruxolitinib 1.0%	Experimental	Drug: Placebo cream, Drug: Ruxolitinib phosphate creamINCB018424 Ruxolitinib 1.0% vs vehicle applied once daily for 28 days
Cohort C: INCB018424 Ruxolitinib 1.5%	Experimental	Drug: Placebo cream, Drug: Ruxolitinib phosphate creamINCB018424 Ruxolitinib 1.5% vs vehicle applied twice for 28 days
Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene	Experimental	Drug: Dovonex® calcipotriene 0.005%INCB018424 up to 1.5% versus Dovonex® calcipotriene 0.005% cream applied BID for 28 days
Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate	Experimental	Drug: Diprolene® AF betamethasone dipropionate 0.05% cream.INCB018424 up to 1.5% versus Diprolene ® AF betamethasone dipropionate 0.05% cream applied twice a day for 28 days

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ruxolitinib phosphate creamAlso: INCB018424Ruxolitinib phosphate cream 0.5%	Drug	Cohort A: INCB018424 Ruxolitinib 0.5%
Dovonex® calcipotriene 0.005%Cream applied once or twice daily for up to 56 days.	Drug	Cohort D: 18424 Ruxolitinib vs Dovonex® calcipotriene
Diprolene® AF betamethasone dipropionate 0.05% cream.Cream applied once or twice daily for up to 56 days	Drug	Cohort E: 18424 Ruxolitinib vs Diprolene® AF betamethasone diproprionate
Placebo creamCream applied once or twice daily for 56 days	Drug	Cohort A: INCB018424 Ruxolitinib 0.5%, Cohort B: INCB018424 Ruxolitinib 1.0%, Cohort C: INCB018424 Ruxolitinib 1.5%
Ruxolitinib phosphate creamAlso: INCB018424Ruxolitinib phosphate cream 1.0%	Drug	Cohort B: INCB018424 Ruxolitinib 1.0%
Ruxolitinib phosphate creamAlso: INCB018424Ruxolitinib phosphate cream 1.5%	Drug	Cohort C: INCB018424 Ruxolitinib 1.5%

Primary outcome

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline
Time frame: Baseline, Days 8, 15, 22, 28 and 56
The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline
Time frame: Baseline, Days 8, 15, 22, 28 and 56
The total target lesion score was calculated by summing the scores for erythema, scaling, and thickness for that particular target lesion. The investigator assessed the severity of the clinical signs erythema, scaling, and thickness for each test site by using a 5-point scale from 0 (no evidence) to 4.0 (severe).
Number of Participants With Treatment Emergent Adverse Events
Time frame: 3 months
A TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug.
Pharmacokinetics Parameter : Skin Flux of INCB018424
Time frame: Days 8, 15, 22, and 28
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each participant.
Pharmacokinetics Parameter : Bioavailability of INCB018424
Time frame: Days 8, 15, 22, and 28
The INCB018424 bioavailability will be estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study. Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect.

1 secondary outcome

Change in Target Lesion Area Compared to Baseline
Time frame: Day 28

Results and safety

Results posted to the registry on 8 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 Cohort A: Vehicle Cream	6	5
Part 1 Cohort A Ruxolitinib 0.5% Cream	6	5
Part 1 Cohort B: Vehicle Cream	6	6
Part 1 Cohort B Ruxolitinib 1.0% Cream	6	6
Part 1 Cohort C: Vehicle Cream	6	6
Part 1 Cohort C Ruxolitinib 1.5% Cream	6	6
Part 2 Cohort D: INCB18424	6	5
Part 2 Cohort D Calcipotriene (Dovonex®)	6	5
Part 2 Cohort E: INCB18424	5	5
Part 2 Cohort E Betamethasone Dipropionate (Diprolene® AF)	5	5

Primary outcome: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline

Time frame: Baseline, Days 8, 15, 22, 28 and 56. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Part 1 Cohort A: Vehicle Cream n = 6	Part 1 Cohort A: Ruxolitinib 0.5% Cream n = 6	Part 1 Cohort B: Vehicle Cream n = 6	Part 1 Cohort B: Ruxolitinib 1.0% Cream n = 6	Part 1 Cohort C: Vehicle Cream n = 6	Part 1 Cohort C: Ruxolitinib 1.5% Cream n = 6	Part 2 Cohort D: INCB18424 n = 6	Part 2 Cohort D: Calcipotriene (Dovonex®) n = 6	Part 2 Cohort E: INCB18424 n = 5	Part 2 Cohort E: Betamethasone Dipropionate (Diprolene® AF) n = 5
Day 8 - Erythema	-0.5 (0.84)	-0.5 (0.55)	-0.8 (0.41)	-1.0 (0.63)	-0.7 (0.82)	-1.2 (0.75)	-1.2 (1.10)	-0.8 (0.84)	-1.0 (0.82)	-1.3 (0.96)
Day 8 - Scaling	-0.2 (0.41)	-0.2 (0.41)	0.0 (0.00)	-0.2 (0.41)	-0.7 (0.82)	-1.2 (0.41)	-0.6 (0.89)	-0.6 (0.55)	-0.8 (0.50)	-0.8 (0.50)
Day 8 - Thickness	-0.7 (1.03)	-0.7 (1.03)	-0.2 (0.41)	-0.3 (0.52)	-0.3 (0.52)	-0.8 (0.75)	-0.4 (0.89)	-0.6 (0.55)	-0.5 (0.58)	-0.8 (0.96)
Day 15 - Erythema	-0.7 (0.82)	-0.7 (0.82)	-0.8 (0.75)	-1.0 (0.63)	-0.5 (0.84)	-1.2 (0.98)	-1.0 (0.71)	-0.8 (0.45)	-1.0 (1.00)	-1.2 (0.84)
Day 15 - Scaling	-0.3 (0.52)	-0.3 (0.52)	-0.2 (0.75)	-0.3 (0.82)	-0.7 (0.82)	-1.0 (0.00)	-0.2 (0.84)	-0.4 (0.55)	-0.8 (0.45)	-1.2 (0.45)
Day 15 - Thickness	-0.3 (0.52)	-0.3 (0.52)	-0.2 (0.41)	-0.3 (0.52)	-0.5 (0.55)	-0.8 (0.41)	-0.6 (1.14)	-0.8 (0.84)	-0.6 (1.14)	-0.6 (0.89)
Day 22 - Erythema	-0.8 (0.84)	-1.0 (0.71)	-1.0 (0.63)	-1.5 (0.84)	-0.3 (0.82)	-1.2 (0.98)	-1.8 (1.30)	-1.0 (1.00)	-1.4 (0.89)	-1.6 (0.55)
Day 22 - Scaling	-0.4 (0.55)	-0.6 (0.55)	-0.5 (0.55)	-0.8 (0.75)	-0.5 (0.84)	-1.2 (0.41)	-0.6 (1.14)	-0.6 (0.89)	-0.8 (0.45)	-1.0 (0.71)

Population analysed: Intent-to-Treat (ITT) population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts).

Primary outcome: Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline

Time frame: Baseline, Days 8, 15, 22, 28 and 56. Mean (Standard Deviation). Unit: Score on Scale

Measure	Part 1 Cohort A: Vehicle n = 6	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n = 6	Part 1 Cohort B: Vehicle n = 6	Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream n = 6	Part 1 Cohort C: Vehicle Cream n = 6	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n = 6	Part 2 Cohort D: INCB18424 n = 6	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) n = 6	Part 2 Cohort E: INCB18424 n = 5	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) n = 5
Day 8	-1.3 (1.97)	-1.3 (1.21)	-1.0 (0.63)	-1.7 (1.37)	-1.7 (2.07)	-3.2 (1.72)	-2.4 (2.70)	-2.2 (1.79)	-2.3 (0.96)	-2.8 (1.71)
Day 15	-1.3 (1.75)	-1.3 (1.75)	-1.3 (2.07)	-2.0 (1.79)	-1.7 (2.07)	-3.0 (1.26)	-2.0 (2.55)	-2.2 (1.79)	-2.4 (2.07)	-3.0 (1.87)
Day 22	-1.4 (1.95)	-2.2 (1.79)	-1.8 (0.98)	-3.0 (2.00)	-1.7 (2.25)	-3.5 (1.76)	-3.6 (3.13)	-2.6 (1.82)	-3.2 (1.64)	-3.4 (1.67)
Day 28	-1.2 (1.30)	-1.0 (1.41)	-2.2 (1.17)	-3.8 (1.60)	-2.2 (1.60)	-3.7 (1.37)	-3.4 (2.70)	-3.2 (1.30)	-3.0 (1.58)	-4.2 (1.79)
Day 56/ET	-1.5 (1.87)	-1.3 (1.21)	0.5 (1.87)	0.5 (1.38)	-1.8 (2.23)	-2.0 (2.10)	-3.2 (1.60)	-3.0 (2.90)	0.0 (2.00)	-1.4 (1.67)

Population analysed: ITT population; 1 subject in Cohort A discontinued due to a protocol violation (Day 28 visit was late, because subject was on vacation) and 1 subject in Cohort D discontinued due to other reason (scheduling conflicts)

Primary outcome: Number of Participants With Treatment Emergent Adverse Events

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n = 6	Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle n = 6	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n = 6	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) n = 5	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) n = 5
Value	6	1	5	4	2

Primary outcome: Pharmacokinetics Parameter : Skin Flux of INCB018424

Time frame: Days 8, 15, 22, and 28. Mean (Standard Deviation). Unit: ng/cm^2/h

Measure	Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream n = 6	Part 1 Cohort B: Ruxolitinib 1.0% Cream Versus Vehicle n = 6	Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream n = 6	Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®) n = 6	Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF) n = 5
Value	54.2 (40.8)	151 (70)	422 (200)	363 (215)	383 (256)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to approximately 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 Cohort A: Ruxolitinib 0.5% Cream vs. Vehicle Cream	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part 1 Cohort B: Ruxolitinib 1.0% Cream vs. Vehicle Cream	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Part 1 Cohort C: Ruxolitinib 1.5% Cream vs. Vehicle Cream	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 2 Cohort D: Ruxolitinib vs. Calcipotriene (Dovonex®)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part 2 Cohort E: Ruxolitinib vs. Betamethasone Dipropionate (Diprolene® AF)	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Total	0 of 29 (0%)	18 of 29 (62.1%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22281165Punwani 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Williams, MD study director

Incyte Corporation

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (time frame: Baseline, Days 8, 15, 22, 28 and 56). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00820950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.