Prurigo NodularisPhase 1NCT06213831
A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream
A Phase 1 study testing Ruxolitinib Cream 1.5% in people with Prurigo Nodularis, run by Incyte Corporation at 20 sites in United States.
Trial summary
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- Ruxolitinib Cream 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 20 sitesUnited States
- Study dates
- 27 Feb 2024to 17 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of PN ≥ 3 months before screening.
- Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
- Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
- IGA-CPG-S score of ≥ 2 at screening and baseline.
- Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
Who cannot join
- Chronic or acute pruritus due to a condition other than PN.
- Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
- Acute or chronic active HBV or HCV infection.
- Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Oakland Hills Dermatology Pc
Auburn Hills, Michigan, 48326
Dermresearch, Inc.
Austin, Texas, 78759
Equity Medical
Bowling Green, Kentucky, 42104
Red River Research Partners
Fargo, North Dakota, 58103
First Oc Dermatology
Fountain Valley, California, 92708
North Texas Center For Clinical Research Ntccr
Frisco, Texas, 75034
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, 46250
St Lukes Clinic Dermatology Ketchum
Ketchum, Idaho, 83340
Advanced Pharma Cr, Llc
Miami, Florida, 33147
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, 37130
Equity Medical, Llc
New York, New York, 10023
Sullivan Dermatology North Miami Beach Office
North Miami Beach, Florida, 33162
Amicis Research Center Valencia
Northridge, California, 91324
Central Sooner Research
Oklahoma City, Oklahoma, 73170
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103
Saguaro Dermatology
Phoenix, Arizona, 85008
Clinical Science Institute Clinical Research Specialists Inc
Santa Monica, California, 90404
Affiliated Dermatology
Scottsdale, Arizona, 85255
Olympian Clinical Research
Tampa, Florida, 33615
Revival Research Institute, Llc Troy
Troy, Michigan, 48084
About this study
Official title: A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).
- Conditions
- Prurigo Nodularis
- Being tested
- Ruxolitinib Cream 1.5%
- Keywords
- Prurigo Nodularis, PN, ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib Cream 1.5%Drug
Ruxolitinib Cream 1.5%
| Study group | Role | What they receive |
|---|---|---|
| Maximal Use Ruxolitinib 1.5% | Experimental | Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions. Receives: Drug: Ruxolitinib Cream 1.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Measured: Up to 16 weeks, including 30 days of safety follow-up
Number of participants with TEAEs leading to dose interruption or discontinuation
Number of participants with TEAEs leading to dose interruption or discontinuation.
Measured: Up to 16 weeks, including 30 days of safety follow-up
Secondary outcomes (1)
Ruxolitinib pharmacokinetic (PK) parameters in plasma
Ruxolitinib concentration in plasma.
Measured: Up to 16 weeks, including 30 days of safety follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start27 Feb 2024
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213831
- Sponsor's protocol ID
- INCB18424-110
- Status last verified
- Aug 2025
- First submitted
- 10 Jan 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT06213831
- Acronym / sponsor ID
- INCB18424-110
- Conditions
- Prurigo Nodularis
- Keywords
- Prurigo Nodularis, PN, ruxolitinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maximal Use Ruxolitinib 1.5% | Experimental | Drug: Ruxolitinib Cream 1.5%Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of PN ≥ 3 months before screening.
- Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
- Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
- IGA-CPG-S score of ≥ 2 at screening and baseline.
- Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
Key exclusion criteria (6 listed)
- Chronic or acute pruritus due to a condition other than PN.
- Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
- Acute or chronic active HBV or HCV infection.
- Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
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 Cream 1.5%Ruxolitinib Cream 1.5% | Drug | Maximal Use Ruxolitinib 1.5% |
Primary outcome
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 16 weeks, including 30 days of safety follow-up
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Number of participants with TEAEs leading to dose interruption or discontinuation
Time frame: Up to 16 weeks, including 30 days of safety follow-up
Number of participants with TEAEs leading to dose interruption or discontinuation.
1 secondary outcome
Ruxolitinib pharmacokinetic (PK) parameters in plasma
Time frame: Up to 16 weeks, including 30 days of safety follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- A study to evaluate the safety and tolerability of maximal use Ruxolitinib CreamLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Incyte Medical Monitor study director
Incyte Corporation
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib Cream 1.5% in people with Prurigo Nodularis, run by Incyte Corporation at 20 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 5 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 16 weeks, including 30 days of safety follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2025.