NCT03697460

Topical Ruxolitinib Lichen Planus

Completed Phase 2 Results posted Last updated 4 August 2021

What this trial tests

Phase 2 trial testing INCB018424 in Lichen Planus in 12 participants. Completed in 25 August 2020.

Timeline

30 August 2018

Primary endpoint
25 June 2020

25 August 2020

Quick facts

Lead sponsor	Aaron R. Mangold
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	30 August 2018
Primary completion	25 June 2020
Estimated completion	25 August 2020
Sites	1 location across United States

Drugs / interventions tested

• INCB018424 — full drug profile →

Conditions studied

• Lichen Planus — all drugs for Lichen Planus →

Sponsor

Aaron R. Mangold

Who can join

18 and older, any sex, with Lichen Planus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Modified Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (mCAILS) Primary · 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

Group	Value	95% CI
INCB018424	11.0	± 6.2

Change in Total Body Lesion Count Primary · week 0, week 4

The number of total body lesions.

Group	Value	95% CI
INCB018424	50	25 – 723

Change in Pruritus Numerical Rating Scale Secondary · week 0, week 4

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.

Group	Value	95% CI
INCB018424	4.4	± 3.0

Change in Overall Quality of Life Skindex-16 Score Secondary · week 0, week 4

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

Group	Value	95% CI
INCB018424	36.3	± 17.5

Number of Subjects With Greater Than or Equal to 50% Improvement in Physician Global Assessment Score Secondary · week 0, week 4

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

Group	Value	95% CI
INCB018424	12

Body Surface Area (BSA) Affected by Cutaneous Lichen Planus Secondary · week 0, week 4

BSA as measured as the percentage of the body affected by Cutaneous Lichen Planus. Ranging from 0-100% of the body.

Week 0

Group	Value	95% CI
INCB018424	6.1	± 7.9

Week 4

Group	Value	95% CI
INCB018424	0.9	± 1.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from baseline to end of study, approximately 12 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

INCB018424

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (13 terms — click to expand)

Reaction	System	INCB018424
Dizziness	Nervous system disorders	—
Abnormal Taste	Nervous system disorders	—
Blood Clot	Blood and lymphatic system disorders	—
Cold	General disorders	—
Fever	General disorders	—
Incontinence	Renal and urinary disorders	—
Light headedness	Nervous system disorders	—
Sleep Disturbance	Psychiatric disorders	—
Pressure on right arm	Musculoskeletal and connective tissue disorders	—
Sinus Infection	Infections and infestations	—
Vaginal Infection	Infections and infestations	—
Vomiting	Gastrointestinal disorders	—
Yeast Infection	Infections and infestations	—

Data from ClinicalTrials.gov NCT03697460 adverse events section.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
   Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
2. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
   Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
3. Lichen Planus.
   Boch K, Langan EA, Kridin K, Zillikens D, et al · · 2021 · cited 84× · PMID 34790675 · DOI 10.3389/fmed.2021.737813
4. Selective Janus Kinase 1 Inhibition Is a Promising Therapeutic Approach for Lupus Erythematosus Skin Lesions.
   Fetter T, Smith P, Guel T, Braegelmann C, et al · · 2020 · cited 48× · PMID 32194562 · DOI 10.3389/fimmu.2020.00344
5. Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis.
   Scuron MD, Fay BL, Connell AJ, Peel MT, et al · · 2020 · cited 19× · PMID 33658996 · DOI 10.3389/fimmu.2020.620098
6. Lichen planus in Germany - epidemiology, treatment, and comorbidity. A retrospective claims data analysis.
   Schruf E, Biermann MH, Jacob J, Häckl D, et al · · 2022 · cited 10× · PMID 35913102 · DOI 10.1111/ddg.14808