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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib Treatment for Lichen Planopilaris | Experimental | Subjects diagnosed with Lichen Planopilaris (LP) will receive Deucravacitinib for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | 6 milligram (mg) orally administrated, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score | 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. | Baseline, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Total abstinence (Periodic abstinence and withdrawal are not acceptable methods of contraception); Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. Oophorectomy alone requires follow up hormone level assessment for fertility; Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject; Barrier methods of contraception: condom or occlusive cap; Use of oral, injected or implanted hormonal methods of contraception or other forms or hormonal contraception that have complete efficacy (failure < 1%). (The dose of the contraceptive should be stable for 3 months).
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Mangold, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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One participant withdrew prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deucravacitinib Treatment for Lichen Planopilaris | Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deucravacitinib Treatment for Lichen Planopilaris | Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score | 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. | Posted | Count of Participants | Participants | 24 weeks |
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Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deucravacitinib Treatment for Lichen Planopilaris | Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Mangold, M.D. | Mayo Clinic | 480-301-6169 | Mangold.Aaron@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2024 | Jun 5, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Change in the Dermatology-LQI Score |
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. |
| Baseline, 24 weeks |
| Change in Pruritus Visual Analogue Scale (VAS) | 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. | Baseline, 24 weeks |
| Change in Pruritus Verbal Rating Scale (VRS) | 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. | Baseline, 24 weeks |
| Change in Numerical Rating Scale (NRS) for Itch | 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 | Baseline, 24 weeks |
| Change in Skindex-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. | Baseline, 24 weeks |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score | 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. | Posted | Count of Participants | Participants | Baseline, 24 weeks |
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| Secondary | Change in the Dermatology-LQI Score | 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. | ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks |
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| Secondary | Change in Pruritus Visual Analogue Scale (VAS) | 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. | ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 weeks |
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| Secondary | Change in Pruritus Verbal Rating Scale (VRS) | 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. | ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks |
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| Secondary | Change in Numerical Rating Scale (NRS) for Itch | 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 | ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks |
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| Secondary | Change in Skindex-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. | ITT analysis; includes a total of 10 subjects, 9 who completed the study and 1 who completed through week 16. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 24 weeks |
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| 0 |
| 11 |
| 1 |
| 11 |
| 11 |
| 11 |
| Colon and Rectal Surgery | Gastrointestinal disorders | Systematic Assessment |
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| Hand Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash/Acne | Infections and infestations | Systematic Assessment |
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| Virus (cold/flu) | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Bakers Cyst | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Canker Sore and Mouth Tenderness | Gastrointestinal disorders | Systematic Assessment |
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| Canker Sores on Tongue | Gastrointestinal disorders | Systematic Assessment |
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| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Gastrointestinal Pain after starting Protopic | Gastrointestinal disorders | Systematic Assessment |
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| Inflammation of Gingiva | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Burning | Gastrointestinal disorders | Systematic Assessment |
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| Mouth Pain | Gastrointestinal disorders | Systematic Assessment |
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| Pain in Right Ear | Ear and labyrinth disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Rash on Neck | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sore Throat/Lymph Nodes | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hair Loss | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Mouth Sore | Gastrointestinal disorders | Systematic Assessment |
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