Trial Outcomes & Findings for A Study of Deucravacitinib to Treat LPP and FFA (NCT NCT06091956)

NCT ID: NCT06091956

Last Updated: 2025-06-08

Results Overview

Number of subjects to have complete or partial response to Deucravacitinib treatment as measured by Lichen Planopilaris Activity Index (LPPAI) score: complete response = LPPAI reduction greater than 85% from baseline score and partial response = LPPAI reduction between 25-85% from baseline score. LPPAI scores range from 0 (no disease) to 10 (most severe) with higher scores indicating worsening disease.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2025-06-08

Participant Flow

One participant withdrew prior to randomization.

Participant milestones

Measure	Deucravacitinib Treatment for Lichen Planopilaris Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Deucravacitinib Treatment for Lichen Planopilaris Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Overall Study Withdrawal by Subject	1
Overall Study Complicating Disease	1

Baseline Characteristics

A Study of Deucravacitinib to Treat LPP and FFA

Baseline characteristics by cohort

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=11 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Age, Continuous	61.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Number of subjects to have complete or partial response to Deucravacitinib treatment as measured by Lichen Planopilaris Activity Index (LPPAI) score: complete response = LPPAI reduction greater than 85% from baseline score and partial response = LPPAI reduction between 25-85% from baseline score. LPPAI scores range from 0 (no disease) to 10 (most severe) with higher scores indicating worsening disease.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=9 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score	9 Participants

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Number of subjects to have an overall response to treatment (Deucravacitinib) as assessed by the physician using PGA. PGA scores range from 0 to 6 with scores between 0-3 indicating a response to treatment.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=9 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score	8 Participants

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16.

Measured by the Dermatology Life Quality Index (DLQI) questionnaire that asks participants to measure their Lichen Planopilaris (LLP) or Frontal Fibrosing Alopecia (FFA) has affected their life over the last month. 10-item questionnaire using a scale of 0 (not at all) to 3 (very much). Maximum score is 30 and minimum score is 0, with higher scores indicating worsening quality of life.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=10 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Change in the Dermatology-LQI Score	0.0 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16.

Subjects are asked on average and at its worst to rate their itch level over the past day by placing a vertical mark on the line with one end indicating no itch and the other end indicating worst imaginable itch. That point will be measured from the "No itch" end, and the number of centimeters (cm) will be reported as the pain score. VAS score interpretation: VAS 0 cm = No itch; VAS <3 cm = Mild itch; VAS ≥3 cm <7 cm = Moderate itch; VAS ≥7 cm <9 cm = Severe itch, VAS ≥9 cm <10 cm = Very severe itch.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=10 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Change in Pruritus Visual Analogue Scale (VAS) Itch Level on Average	-1.6 units on a scale Standard Deviation 3.0
Change in Pruritus Visual Analogue Scale (VAS) Itch Level at its Worst	-2.7 units on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16.

Subjects are asked on average and at its worst to rate their itch in the last 24 hours using a scale of 0= none, 1-mild, 2=moderate, 3= severe. Scores range from 0-3, with higher scores indicating worsening itch.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=10 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Change in Pruritus Verbal Rating Scale (VRS) Itch level on average	-0.9 score on a scale Standard Deviation 0.7
Change in Pruritus Verbal Rating Scale (VRS) Itch level at its worst	-0.9 score on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16.

Itch is measured using numerical rating scale 0-10; 0= no itch, 1-4 = mild itch, 4-7 = moderate itch, 7-9 = severe itch, 10= very severe itch

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=10 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Change in Numerical Rating Scale (NRS) for Itch	-1.9 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16.

Measured by the Skindex-16 scoring system focused on itch and its impact upon quality of life. 16-item questionnaire using a scale of 0=never bothered to 6=always bothered, total score 0 to 96 with higher score indicated worse quality of life.

Outcome measures

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=10 Participants Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Change in Skindex-16	-21.0 score on a scale Standard Deviation 22.1

Adverse Events

Deucravacitinib Treatment for Lichen Planopilaris

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=11 participants at risk Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Gastrointestinal disorders Diverticulitis	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Colon and Rectal Surgery	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.

Other adverse events

Measure	Deucravacitinib Treatment for Lichen Planopilaris n=11 participants at risk Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily
Skin and subcutaneous tissue disorders Acne	81.8% 9/11 • Number of events 9 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Skin and subcutaneous tissue disorders Hand Dermatitis	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Infections and infestations Rash/Acne	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
General disorders Virus (cold/flu)	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Nervous system disorders Headache	9.1% 1/11 • Number of events 2 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Musculoskeletal and connective tissue disorders Bakers Cyst	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Canker Sore and Mouth Tenderness	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Canker Sores on Tongue	18.2% 2/11 • Number of events 2 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Infections and infestations Upper Respiratory Infection	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
General disorders Fever	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Gastrointestinal Pain after starting Protopic	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Inflammation of Gingiva	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Mouth Burning	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Mouth Pain	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Ear and labyrinth disorders Pain in Right Ear	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Diverticulitis	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Skin and subcutaneous tissue disorders Rash on Neck	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Respiratory, thoracic and mediastinal disorders Sore Throat/Lymph Nodes	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Skin and subcutaneous tissue disorders Hair Loss	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Gastrointestinal disorders Mouth Sore	9.1% 1/11 • Number of events 1 • Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.

Additional Information

Aaron Mangold, M.D.

Mayo Clinic

Phone: 480-301-6169

Email: Mangold.Aaron@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place