Lichen PlanusPhase 2NCT03697460
Topical Ruxolitinib Lichen Planus
A Phase 2 study testing INCB018424 in people with Lichen Planus, run by Aaron R. Mangold at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus
- What is being tested?
- INCB018424
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 25 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator.
Subjects must give written, signed, and dated informed consent before any study related activity is performed.
When appropriate, a legal representative will sign the informed consent according to local laws and regulation
Both men and women must be at least 18 years of age at the time of screening
Subjects must have clinical and histological features of LP
LP must involve between 2 and 20% of the BSA
Subjects must have a minimum of 10 lesions of LP
Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP
Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INCB018424 in the Treatment of Cutaneous Lichen Planus
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.
Read the detailed description
This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.
- Conditions
- Lichen Planus
- Being tested
- INCB018424
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB018424Drug
INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
| Study group | Role | What they receive |
|---|---|---|
| INCB018424 | Experimental | INCB018424 Cream Receives: Drug: INCB018424 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)
mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity
Measured: week 0, week 4
Change in Total Body Lesion Count
The number of total body lesions.
Measured: week 0, week 4
Secondary outcomes (4)
Change in Pruritus Numerical Rating Scale
Pruritus Numerical Rating Scale as measured by they question "How severe has your itching been over the last 24 hours?" Ranging from 0 = none, to 10 = severe. The higher the score the more severe.
Measured: week 0, week 4
Change in Overall Quality of Life Skindex-16 Score
Skindex-16 score as measured by 16 questions, 3 subscales: Symptoms, Emotional, Functional. Score ranges for each question (0-6). Total score ranging from 0-96 with higher score indicating worse quality of life
Measured: week 0, week 4
Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score
PGA score as measured by Grade 0 (clear: no evidence of disease (100% improvement)) to Grade 6 (Worse, disease is worse than at baseline evaluation by (≥25%) or more). Higher score equals worse disease
Measured: week 0, week 4
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus
BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body.
Measured: week 0, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start30 Aug 2018
- Primary completion25 Jun 2020
- Study completion25 Aug 2020
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 Lichen PlanusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Topical INCB018424
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron R. Mangold
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron R. Mangold, Mayo Clinic
- Investigators
- Aaron R Mangold, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697460
- Sponsor's protocol ID
- 17-005406
- Status last verified
- Aug 2021
- First submitted
- 3 Oct 2018
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brumfiel CM, Patel MH, Severson KJ, Zhang N, Li X, Quillen JK, Zunich SM, Branch EL, Nelson SA, Pittelkow MR, Mangold AR. Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. J Invest Dermatol. 2022 Aug;142(8):2109-2116.e4. doi: 10.1016/j.jid.2022.01.015. Epub 2022 Feb 5.
PubMed 35131254
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCB018424 in the Treatment of Cutaneous Lichen Planus
- ClinicalTrials.gov ID
- NCT03697460
- Acronym / sponsor ID
- 17-005406
- Conditions
- Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aaron R. MangoldUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 4 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.
Detailed description
This is a single center, exploratory, open-label, single-arm design study of 12 patients. Treatment naïve and treatment refractory patients with LP will be treated with INCB018424 PHOSPHATE CREAM. Patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. The study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). The screening and washout period will allow for treatment naïve/ new diagnosis LP to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. The total duration of the study will be 13-16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topical INCB018424
| Arm | Type | Receives |
|---|---|---|
| INCB018424 | Experimental | Drug: INCB018424INCB018424 Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| INCB018424INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. | Drug | INCB018424 |
Primary outcome
Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS)
Time frame: week 0, week 4
mCAILS summation score as measured by Erythema (0-8), Scaling (0-8) Plaque elevation (0-8) Hyper/hypopigmentation (0-8) Size (0-18), Total score ranging from 0-50 with higher score indicating higher severity
Change in Total Body Lesion Count
Time frame: week 0, week 4
The number of total body lesions.
4 secondary outcomes
Change in Pruritus Numerical Rating Scale
Time frame: week 0, week 4
Change in Overall Quality of Life Skindex-16 Score
Time frame: week 0, week 4
Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score
Time frame: week 0, week 4
Body Surface Area (BSA) Affected by Cutaneous Lichen Planus
Time frame: week 0, week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35131254Brumfiel CM, Patel MH, Severson KJ, Zhang N, Li X, Quillen JK, Zunich SM, Branch EL, Nelson SA, Pittelkow MR, Mangold AR. Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. J Invest Dermatol. 2022 Aug;142(8):2109-2116.e4. doi: 10.1016/j.jid.2022.01.015. Epub 2022 Feb 5.
- Mayo Clinic Clinical TrialsLink 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.
Aaron R Mangold principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB018424 in people with Lichen Planus, run by Aaron R. Mangold at 1 site 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?
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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 Aug 2021). 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 Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) (time frame: week 0, week 4). 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?
On the ClinicalTrials.gov record for NCT03697460, 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 4 Aug 2021.