Topical Ruxolitinib Lichen Planus

NCT03697460 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-005406
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lichen Planus

Outcome Measures

Primary Outcomes (2)

• 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

  week 0, week 4

• Change in Total Body Lesion Count

  The number of total body lesions.

  week 0, week 4

Secondary Outcomes (4)

• Change in Pruritus Numerical Rating Scale

  week 0, week 4

• Change in Overall Quality of Life Skindex-16 Score

  week 0, week 4

• Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score

  week 0, week 4

• Body Surface Area (BSA) Affected by Cutaneous Lichen Planus

  week 0, week 4

Study Arms (1)

INCB018424

EXPERIMENTAL

INCB018424 Cream

Drug: INCB018424

Interventions

INCB018424 DRUG

INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.

INCB018424

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aaron R. Mangold: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• 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.

  PMID: 35131254 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lichen Planus

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

All subjects reached the 4 week endpoint. Due to surrounding the Covid-19 pandemic, 2 subjects did not complete weeks 8 or 12 and 1 subject did not complete week 12.

Results Point of Contact

• Title: Aaron R. Mangold, M.D.
• Organization: Mayo Clinic

Mangold.Aaron@mayo.edu

480-301-6479

Study Officials

• Aaron R Mangold

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: Topical INCB018424

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: August 30, 2018
• Primary Completion: June 25, 2020
• Study Completion: August 25, 2020
• Last Updated: August 4, 2021
• Results First Posted: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)