A Phase 2 interventional study of Deucravacitinib in Lichen Planopilaris, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
The purpose of this clinical research study is to learn more about the use of Deucravacitinib in the treatment of Lichen Planopilaris.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's enrollment of 12 is below the median of 30 across 55 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects diagnosed with Lichen Planopilaris (LP) will receive Deucravacitinib for 24 weeks.
Drug: Deucravacitinib
6 milligram (mg) orally administrated, twice daily
Also known as: BMS-986165
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.
Time frame: 24 weeks
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.
Time frame: Baseline, 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline, 24 weeks
| Milestone | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Started | 11 |
| Completed | 9 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Complicating disease | 1 |
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.
| Participants | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Complete and Partial Response to Deucravacitinib Measured by Lichen Planopilaris Activity Index (LPPAI) Score | 9 |
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.
| Participants | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Response to Deucravacitinib Measured by Physician Global Assessment (PGA) Score | 8 |
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.
| score on a scale | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Change in the Dermatology-LQI Score | 0.0 ± 4.2 |
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.
| units on a scale | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Itch Level on Average | -1.6 ± 3.0 |
| Itch Level at its Worst | -2.7 ± 3.8 |
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.
| score on a scale | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Itch level on average | -0.9 ± 0.7 |
| Itch level at its worst | -0.9 ± 0.6 |
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
| score on a scale | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Change in Numerical Rating Scale (NRS) for Itch | -1.9 ± 3.3 |
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.
| score on a scale | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Change in Skindex-16 | -21.0 ± 22.1 |
Collected over Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deucravacitinib Treatment for Lichen Planopilaris | 0/11 (0%) | 1/11 (9.1%) | 11/11 (100%) |
| Event | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| DiverticulitisGastrointestinal disorders | 1/11 |
| Colon and Rectal SurgeryGastrointestinal disorders | 1/11 |
| Event | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| AcneSkin and subcutaneous tissue disorders | 9/11 |
| Canker Sores on TongueGastrointestinal disorders | 2/11 |
| Hand DermatitisSkin and subcutaneous tissue disorders | 1/11 |
| RashSkin and subcutaneous tissue disorders | 1/11 |
| Rash/AcneInfections and infestations | 1/11 |
| Virus (cold/flu)General disorders | 1/11 |
| HeadacheNervous system disorders | 1/11 |
| Bakers CystMusculoskeletal and connective tissue disorders | 1/11 |
| Canker Sore and Mouth TendernessGastrointestinal disorders | 1/11 |
| Upper Respiratory InfectionInfections and infestations | 1/11 |
| Age, Continuous(years) | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Mean | 61.6 ± 11.1 |
| Sex: Female, Male(Participants) | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Female | 8 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 11 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Deucravacitinib Treatment for Lichen Planopilaris |
|---|---|
| United States | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2023 to primary completion in May 2024, 6 months.
Results were first posted in Jun 2025, 1 year after primary completion.
Of 16 phase 2 interventional studies under Lichen Planus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deucravacitinib