A Phase 3 interventional study of Delgocitinib and Cream Vehicle in Lichen Sclerosus, sponsored by LEO Pharma. Recruiting at 33 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment
The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream compared with cream vehicle in the treatment of adult participants with mild to severe lichen sclerosus (LS). The researchers are focusing on female participants because LS is more likely to affect females compared to males.
The trial is conducted in 2 parts. Part 1 of the trial enrolls female participants with LS and results in the selection of the optimal dose for Part 2. The selected dose will then be evaluated in Part 2, which will enroll both female and male participants. Assessment of efficacy and safety of delgocitinib cream in male participants with LS will be evaluated in a substudy.
For each participant, the trial will last at least 55 weeks and up to 60 weeks.
30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.
This study's planned enrollment of 652 is above the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.
Browse Lichen Sclerosus et Atrophicus studies →LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 24 (75%) 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.
Female participants or male participants (assigned sex at birth and has not had any gender affirming medical procedures to their genital area) with LS in the anogenital area, regardless of treatment history. The diagnosis must be based on typical clinical features and supported by . A biopsy must be taken if there is no previous documented biopsy to support the diagnosis.
Note: Participants who also have LS-affected areas outside the anogenital area are allowed to be enrolled but these areas will not be treated with medicinal product (IMP). Participants with newly diagnosed LS can be included, as well as participants who have progressive LS (including existing architectural changes).
Exclusion Criteria
Female participants: Suspected clinically (or confirmed diagnostically) of having active infection in the anogenital area, including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma genitalium, bacterial vaginosis, or herpes simplex. Participants who test positive for sexually transmitted disease (STD)/bacterial vaginosis (BV)/anogenital candidiasis during screening can be treated, and if repeat testing is negative, these participants can be enrolled. If treatment is needed, the screening period can be extended to 6 weeks to accommodate the treatment and washout requirements.
Male participants: Suspected clinically (or confirmed diagnostically) of having active infection in the anogenital area, including candidiasis, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, or herpes simplex. Participants who test positive for STD/anogenital candidiasis during screening can be treated, and if repeat testing is negative, these participants can be enrolled. If treatment is needed, the screening period can be extended to 6 weeks to accommodate the treatment and washout requirements.
infection within 4 weeks prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial.
Clinically significant infections are defined as:
History of cancer:
Participants who have had other malignancies (except vulvar SCC) are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to screening.
Participants who have had other malignancies (except penile SCC) are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to screening.
Any disorder which is not stable and according to the investigator could:
Examples include, but are not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, immunological, and psychiatric disorders, and major physical impairment.
Any abnormal finding which according to the investigator may:
The abnormal finding must be clinically significant and observed during the screening period. Examples include abnormal findings in physical examination, vital signs, (ECG), hematology, or biochemistry.
Treatment with any marketed biological therapy or biologic agents:
Clinically important laboratory abnormalities:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
Participants will receive delgocitinib cream 20 mg/g twice daily (BID) in both the 12-week initial treatment period and the 40-week continuation treatment period.
Drug: Delgocitinib
Participants will receive delgocitinib cream 20 mg/g BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Drug: Delgocitinib
Participants will receive delgocitinib cream 8 mg/g BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream 20 mg/g BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream 8 mg/g BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Drug: Cream Vehicle
Participants will receive delgocitinib cream, at the selected dose from Part 1, BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Drug: Delgocitinib
Participants will receive delgocitinib cream, at the selected dose from Part 1, BID in the 12-week initial treatment period, then cream vehicle BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive cream vehicle BID in the 12-week initial treatment period, then delgocitinib cream, at the selected dose from Part 1, BID in the 40-week continuation treatment period.
Drug: Delgocitinib · Drug: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period.
Drug: Cream Vehicle
Participants will receive delgocitinib BID via topical application.
Participants will receive cream vehicle BID via topical administration.
Number of Participants Achieving IGA-LS TS at Week 12
Time frame: Week 12
Number of Participants Achieving IGA-LS TS at Week 8
Time frame: Week 8
Change in Clinical Lichen Sclerosus Score (CLISSCO) from Baseline to Week 12
Time frame: Baseline to Week 12
Number of Participants Achieving a Reduction of Skin Pain Numerical Rating Scale (NRS) Score (Weekly Average) of ≥4 Points from Baseline to Week 12 in Participants with Baseline Skin Pain NRS Score ≥4
Time frame: Baseline to Week 12
Number of Participants Achieving a Reduction of Skin Pain NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 8 in Participants with Baseline Skin Pain NRS Score ≥4
Time frame: Baseline to Week 8
Number of Participants Achieving a Reduction of Itch NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 12 in Participants with Baseline Itch NRS Score ≥4
Time frame: Baseline to Week 12
Number of Participants Achieving a Reduction of Itch NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 8 in Participants with Baseline Itch NRS Score ≥4
Time frame: Baseline to Week 8
Change in Vulvar Quality of Life Index (VQLI) Score from Baseline to Week 12
Time frame: Baseline to Week 12
Number of Participants Achieving IGA-LS TS at Week 52
Time frame: Week 52
Change in CLISSCO Score from Baseline to Week 52
Time frame: Baseline to Week 52
Number of Participants Achieving IGA-LS TS at Week 52 Among Participants Having Achieved IGA-LS TS at Week 12
Time frame: Week 52
Number of Participants Achieving an IGA-LS Score of 0 or 1 at Week 52 Among Participants Having Achieved IGA-LS TS at Week 12
Time frame: Week 52
Time to IGA-LS TS from Baseline to Week 52
Time frame: Baseline to Week 52
Time to IGA-LS ≥2 from Week 12 to Week 52 Among Participants Having Achieved IGA-LS TS at Week 12
Time frame: Week 12 to Week 52
Number of Participants Having no Increase in CLISSCO Architectural Changes Domain Score from Baseline to Week 52
Time frame: Baseline to Week 52
Number of Participants Achieving a Reduction of Skin Pain NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 52 in Participants with Baseline Skin Pain NRS Score ≥4
Time frame: Baseline to Week 52
Number of Participants Achieving a Reduction of Itch NRS Score (Weekly Average) of ≥4 Points from Baseline to Week 52 in Participants with Baseline Itch NRS Score ≥4
Time frame: Baseline to Week 52
Number of Treatment-emergent Adverse Events (TEAEs) from Baseline to Week 12
Time frame: Baseline to Week 12
Number of TEAEs from Week 12 to Week 54
Time frame: Week 12 to Week 54
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Delgocitinib
Lichen Sclerosus et Atrophicus →