PsoriasisPhase 2NCT00617994

Open Label, Safety and Efficacy Study of Topical Investigational Drug to Treat Patients With Psoriasis

A Phase 2 study testing Ruxolitinib in people with Psoriasis, run by Incyte Corporation at 4 sites in United States.

Completed

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

Trial summary

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Psoriasis
What is being tested?: Ruxolitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesUnited States
Study dates: 31 Aug 2007to 31 May 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must have psoriatic lesions measuring protocol specific BSA

Who cannot join

Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
Pustular psoriasis or erythroderma

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Austin, Texas, 78759
Study site
College Station, Texas, 77840
Study site
Fridley, Minnesota, 55432
Study site
Rochester, New York, 14623

Other trials in United States

About this study

Official title: An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Conditions: Psoriasis
Being tested: Ruxolitinib
Keywords: psoriasis
Medical subject headings: Psoriasis

What participants receive

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

RuxolitinibDrug
Also called INCB018424
Ruxolitinib 1.5% cream BID for 28 days

Study groups in NCT00617994
Study group	Role	What they receive
Group A	Experimental	Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA. Receives: Drug: Ruxolitinib
Group B	Experimental	Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1. Receives: Drug: Ruxolitinib
Group C	Experimental	Patients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2. Receives: Drug: Ruxolitinib

What is being measured

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

Number of Treatment of Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Measured: Approximately 3 months
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was 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.
Measured: Days 1, 4, 8, 15, 22, and 28-30
Pharmacokinetics Parameter: Bioavailability of INCB018424
The INCB018424 bioavailability was 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.
Measured: Approximately one month: Days 1, 4, 8, 15, 22, and 28
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Measured: Approximately one month: Days 1, 4, 8, 15, 22, and 28

Secondary outcomes (3)

Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
Measured: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
Mean Change in Psoriatic Lesion Area
The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Measured: Days 1 and 28
Mean Change in Physicians Global Assessment Score
The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments.
Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Measured: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later

Timeline

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

31 Aug 200731 May 2009

First posted18 Feb 2008 (estimated)
Study start31 Aug 2007
Primary completion30 Apr 2009
Study completion31 May 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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00617994
Sponsor's protocol ID: INCB 18424-202
Status last verified: Feb 2022
First submitted: 21 Jan 2008
Last updated: 8 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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: An Open Label, Safety, Tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD) and Preliminary Efficacy Study of Ruxolitinib When Applied to Patients With Plaque Psoriasis Involving 2 - 20% Body Surface Area (BSA).
ClinicalTrials.gov ID: NCT00617994
Acronym / sponsor ID: INCB 18424-202
Conditions: Psoriasis
Keywords: psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 31 Aug 2007 (actual)
Primary completion: 30 Apr 2009 (actual)
Study completion: 31 May 2009 (actual)
First posted: 18 Feb 2008 (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.

This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Drug: RuxolitinibPatients with active stable plaque psoriasis treated with topical cream application on lesions involving a small percent BSA.
Group B	Experimental	Drug: RuxolitinibPatients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 1.
Group C	Experimental	Drug: RuxolitinibPatients with active stable plaque psoriasis treated with topical cream application on lesions involving a larger percent BSA than Cohort 2.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects must have psoriatic lesions measuring protocol specific BSA

Key exclusion criteria (2 listed)

Lesions solely involving the palms of the hands, the soles of the feet, the intertriginious areas, the scalp or the face
Pustular psoriasis or erythroderma

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
RuxolitinibAlso: INCB018424Ruxolitinib 1.5% cream BID for 28 days	Drug	Group A, Group B, Group C

Primary outcome

Number of Treatment of Emergent Adverse Events
Time frame: Approximately 3 months
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Pharmacokinetics Parameter : Skin Flux of INCB018424
Time frame: Days 1, 4, 8, 15, 22, and 28-30
The INCB018424 skin flux was 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.
Pharmacokinetics Parameter: Bioavailability of INCB018424
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
The INCB018424 bioavailability was 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.
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.

3 secondary outcomes

Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Time frame: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
Mean Change in Psoriatic Lesion Area
Time frame: Days 1 and 28
Mean Change in Physicians Global Assessment Score
Time frame: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later

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
Cohort A	5	5
Cohort B	5	5
Cohort C	5	5
Cohort D	5	5
Cohort E	5	5

Primary outcome: Number of Treatment of Emergent Adverse Events

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

Measure	Cohort A n = 5	Cohort B n = 5	Cohort C n = 5	Cohort D n = 5	Cohort E n = 5
Value	2	4	2	1	2

Primary outcome: Pharmacokinetics Parameter : Skin Flux of INCB018424

Time frame: Days 1, 4, 8, 15, 22, and 28-30. Mean (Standard Deviation). Unit: ng/cm^2/h

Measure	Cohort A n = 5	Cohort B n = 5	Cohort C n = 5	Cohort D n = 5	Cohort E n = 5
Value	180 (126)	131 (92)	60 (43)	151 (126)	152 (74)

Primary outcome: Pharmacokinetics Parameter: Bioavailability of INCB018424

Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28. Mean (Standard Deviation). Unit: percentage

Measure	Cohort A n = 5	Cohort B n = 5	Cohort C n = 5	Cohort D n = 5	Cohort E n = 5
Value	3.8 (2.5)	4.1 (3.4)	3.4 (1.9)	3.9 (1.3)	5.2 (1.9)

Primary outcome: Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424

Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28. Mean (Standard Deviation). Unit: nM

Measure	Cohort A n = 5	Cohort B n = 5	Cohort C n = 5	Cohort D n = 5	Cohort E n = 5
Value	7.00 (2.10)	28.38 (13.10)	24.41 (10.07)	34.97 (20.44)	60.98 (73.85)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Cohort B	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Cohort C	1 of 5 (20%)	2 of 5 (40%)	0 of 5
Cohort D	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Cohort E	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Total	1 of 25 (4%)	11 of 25 (44%)	0 of 25

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.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ruxolitinib in people with Psoriasis, run by Incyte Corporation at 4 sites in United States.

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 1 inclusion and 2 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 4 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?

Number of Treatment of Emergent Adverse Events (time frame: Approximately 3 months). The study lists 4 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 NCT00617994.

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.