Lichen SclerosusPhase 3DELTA CARE 1NCT07335588
A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus
A Phase 3 study testing Delgocitinib in people with Lichen Sclerosus, run by LEO Pharma at 33 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Sclerosus
- What is being tested?
- Delgocitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 652 participants
- Where
- 33 sitesin 3 countries
- Study dates
- 1 May 2026to 29 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Age ≥18 years at the time of signing informed consent.
- Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
- 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 biopsy. 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 investigational medicinal product (IMP). Participants with newly diagnosed LS can be included, as well as participants who have progressive LS (including existing architectural changes).
- Disease severity graded as mild to severe at screening and baseline according to IGA-LS score (ie, an IGA-LS score of ≥2).
- Female participants: A woman of childbearing potential (WOCBP) must agree to use a highly effective or acceptable form of birth control throughout the trial up until the last application of IMP. Male participants: Contraceptive requirements are not applicable for male participants.
Who cannot join
- Participants with atypical presentation of LS in the anogenital area where the diagnosis is uncertain, or the suspicion of malignancy exists.
- Female participants: History of vulvar squamous cell carcinoma (SCC), including precursor lesions (eg, human papillomavirus-independent [HPV-I] vulvar intraepithelial neoplasia [VIN] and high-grade squamous intraepithelial lesion). Male participants: History of penile SCC, including precursor lesions.
- Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV) screening test.
- Active dermatologic or gynecologic conditions that could confound the diagnosis of LS or interfere with assessment of the IMP (eg, urinary incontinence-associated dermatitis, genital lichen planus, and genital psoriasis), as assessed by the investigator.
- Participants with severe urinary incontinence. Incontinence is considered severe if it occurs on most days and more than a few drops at a time.
- 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.
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- 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.
- Clinically significant 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:
- A systemic infection.
- A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.
- History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
- Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the trial period.
- History of cancer:
- Female participants: Participants who have had basal cell carcinoma or localized SCC of the skin (outside the anogenital area), or in situ carcinoma of the cervix are eligible provided that curative therapy was successfully completed at least 12 months prior to screening.
- 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.
- Male participants: Participants who have had basal cell carcinoma or localized SCC of the skin (outside the anogenital area) are eligible provided that curative therapy was successfully completed at least 12 months 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.
- Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive for hepatitis B virus deoxyribonucleic acid (participants who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus deoxyribonucleic acid are negative), or positive hepatitis C virus antibody serology confirmed by hepatitis C virus ribonucleic acid (RNA) at screening.
- Known or suspected hypersensitivity to any component(s) of the IMP(s).
- Any disorder which is not stable and according to the investigator could:
- Affect the safety of the participant throughout the trial.
- Hinder the participant's ability to complete the trial.
- 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:
- Put the participant at risk because of their participation in the trial.
- Influence the participant's ability to complete the trial.
- The abnormal finding must be clinically significant and observed during the screening period. Examples include abnormal findings in physical examination, vital signs, electrocardiogram (ECG), hematology, or biochemistry.
- Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
- Female participants only: Women who are pregnant or lactating. For women of childbearing potential, a negative pregnancy test is required at screening.
- Systemic treatment with immunosuppressive drugs (eg, methotrexate, cyclosporine), immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
- Cutaneously applied treatment with immunomodulators (eg, topical calcineurin inhibitor [TCI]) or topical corticosteroid (TCS) on the anogenital area within 2 weeks before baseline.
- Use of systemic or topical Janus kinase (JAK) inhibitors (including delgocitinib) within 4 weeks before baseline.
- Systemic or cutaneous (applied in the anogenital area) use of antibiotics, antiparasitics, antivirals, or antifungals within 1 week before baseline.
- Treatment with any marketed biological therapy or investigational biologic agents:
- Any cell-depleting agent including but not limited to rituximab: within 6 months prior to baseline, or until the lymphocyte count returns to normal, whichever is longer.
- Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- Treatment with any non-marketed drug substance (that is, an agent that has not yet been made available for clinical use following registration) within 4 weeks prior to baseline or 5 half-lives, whichever is longer.
- Light-based therapy on the anogenital area and treatments with platelet-rich plasma within 4 weeks prior to baseline.
- Cutaneous treatments applied within 1 week before baseline in regions other than the anogenital area which could interfere with clinical trial evaluations or pose a safety concern.
- Other cutaneous therapies or therapeutic procedures on the anogenital area within 1 week before baseline.
- Surgical treatment for anogenital LS in the past 6 months or have not recovered fully from an earlier surgical procedure in the anogenital area.
- Female participants only: Participants who are receiving doses that are not stable for topical estrogens (<4 weeks before screening), and hormonal contraceptives and hormone replacement therapy (HRT) medications (<3 months before screening).
- Current participation in any other interventional clinical trial.
- Previously randomized in this clinical trial.
- Previously randomized in a clinical trial with delgocitinib.
- Clinically important laboratory abnormalities:
- Participants with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values ≥2×the upper limit of normal (ULN) with total bilirubin (BIL) ≥1.5×ULN (unless elevated BIL is related to Gilbert Meulengracht Syndrome).
- Participants with ALT and/or AST values ≥3×ULN.
- Participants with severe renal impairment (estimated glomerular filtration rate [eGFR]<30 mL/min/1.73 m2).
- Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.
- Participants who are legally institutionalized.
- Only applicable in France: Participant not affiliated with or not a beneficiary of a social security scheme.
- Male participants only: Participants who currently need or are expected during the entire study period to require any type of surgical treatment for LS (eg, circumcision, urethroplasty, adhesiolysis) or tool-assisted local treatment (eg, catheter, cotton swabs, applicators, dilators, etc.) for LS involving the urethra. Application of study treatment of the urethral meatus is allowed if it can be applied by the participant's hand or fingers only.
Trial locations and contacts
33 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 3 countries
United States20 sites, 20 recruiting
- Recruiting
LEO Pharma Investigational Site
Bexley, Ohio, 43209
- Recruiting
LEO Pharma Investigational Site
Birmingham, Alabama, 35244
- Recruiting
LEO Pharma Investigational Site
Boca Raton, Florida, 33486
- Recruiting
LEO Pharma Investigational Site
Chapel Hill, North Carolina, 27516
- Recruiting
LEO Pharma Investigational Site
Clearwater, Florida, 33756
- Recruiting
LEO Pharma Investigational Site
Dallas, Texas, 75235
- Recruiting
LEO Pharma Investigational Site
Fremont, California, 94538
- Recruiting
LEO Pharma Investigational Site
Jacksonville, Florida, 32224
- Recruiting
LEO Pharma Investigational Site
Miami, Florida, 33186
- Recruiting
LEO Pharma Investigational Site
Middlebury, Connecticut, 06762
- Recruiting
LEO Pharma Investigational Site
Murray, Utah, 84107
- Recruiting
LEO Pharma Investigational Site
New York, New York, 10029
- Recruiting
LEO Pharma Investigational Site
New York, New York, 10036
- Recruiting
LEO Pharma Investigational Site
Northville, Michigan, 48167
- Recruiting
LEO Pharma Investigational Site
Phoenix, Arizona, 85006
- Recruiting
LEO Pharma Investigational Site
Portland, Oregon, 97239
- Recruiting
LEO Pharma Investigational Site
Rochester, Minnesota, 55905
- Recruiting
LEO Pharma Investigational Site
Scottsdale, Arizona, 85259
- Recruiting
LEO Pharma Investigational Site
Tampa, Florida, 33609
- Recruiting
LEO Pharma Investigational Site
Washington D.C., District of Columbia, 20037
Canada11 sites, 11 recruiting
- Recruiting
LEO Pharma Investigational Site
Fredericton, New Brunswick, E3B 1G9
- Recruiting
LEO Pharma Investigational Site
Guelph, Ontario, N1L 0B7
- Recruiting
LEO Pharma Investigational Site
Montreal, Quebec, H1Y 3L1
- Recruiting
LEO Pharma Investigational Site
Newmarket, Ontario, L3Y 2R2
- Recruiting
LEO Pharma Investigational Site
Québec, Quebec, G1W 4R4
- Recruiting
LEO Pharma Investigational Site
Richmond Hill, Ontario, L4E 4L6
- Recruiting
LEO Pharma Investigational Site
Saskatoon, Saskatchewan, S7K 2C1
- Recruiting
LEO Pharma Investigational Site
Toronto, Ontario, M3B 0A7
- Recruiting
LEO Pharma Investigational Site
Toronto, Ontario, M4W 2N4
- Recruiting
LEO Pharma Investigational Site
Waterloo, Ontario, N2J 1C4
- Recruiting
LEO Pharma Investigational Site
Winnipeg, Manitoba, R3M 3Z4
United Kingdom2 sites, 2 recruiting
- Recruiting
LEO Pharma Investigational Site
Liverpool, L69 3BX
- Recruiting
LEO Pharma Investigational Site
London, SE1 9RT
About this study
Official title: A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period
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.
- Conditions
- Lichen Sclerosus
- Being tested
- Delgocitinib, Cream Vehicle
- Medical subject headings
- Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelgocitinibDrug
Participants will receive delgocitinib BID via topical application.
Cream VehicleDrug
Participants will receive cream vehicle BID via topical administration.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Delgocitinib Cream 20 mg/g | Experimental | 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. Receives: Drug: Delgocitinib |
| Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 1: Delgocitinib Cream 8 mg/g | Experimental | Participants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period. Receives: Drug: Delgocitinib |
| Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 1: Cream Vehicle | Placebo comparator | Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. Receives: Drug: Cream Vehicle |
| Part 2: Delgocitinib Cream (Selected Dose) | Experimental | 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. Receives: Drug: Delgocitinib |
| Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose) | Experimental | 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. Receives: Drug: Delgocitinib; Drug: Cream Vehicle |
| Part 2: Cream Vehicle | Placebo comparator | Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. Receives: Drug: Cream Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving IGA-LS TS at Week 12
Measured: Week 12
Secondary outcomes (18)
Number of Participants Achieving IGA-LS TS at Week 8
Measured: Week 8
Change in Clinical Lichen Sclerosus Score (CLISSCO) from Baseline to Week 12
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Week 8
Change in Vulvar Quality of Life Index (VQLI) Score from Baseline to Week 12
Measured: Baseline to Week 12
Number of Participants Achieving IGA-LS TS at Week 52
Measured: Week 52
Change in CLISSCO Score from Baseline to Week 52
Measured: Baseline to Week 52
Number of Participants Achieving IGA-LS TS at Week 52 Among Participants Having Achieved IGA-LS TS at Week 12
Measured: 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
Measured: Week 52
Time to IGA-LS TS from Baseline to Week 52
Measured: 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
Measured: Week 12 to Week 52
Number of Participants Having no Increase in CLISSCO Architectural Changes Domain Score from Baseline to Week 52
Measured: 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
Measured: 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
Measured: Baseline to Week 52
Number of Treatment-emergent Adverse Events (TEAEs) from Baseline to Week 12
Measured: Baseline to Week 12
Number of TEAEs from Week 12 to Week 54
Measured: Week 12 to Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 May 2026
- Primary completion10 Mar 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335588
- Sponsor's protocol ID
- LP0133-2395
- Other IDs
- 2025-524873-17-00, U1111-1333-1675, 2025
- Acronym
- DELTA CARE 1
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream in Adult Participants With Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period
- ClinicalTrials.gov ID
- NCT07335588
- Acronym / sponsor ID
- DELTA CARE 1 / LP0133-2395
- Conditions
- Lichen Sclerosus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: Delgocitinib Cream 20 mg/g | Experimental | Drug: DelgocitinibParticipants 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. |
| Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 1: Delgocitinib Cream 8 mg/g | Experimental | Drug: DelgocitinibParticipants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
| Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 1: Cream Vehicle | Placebo comparator | Drug: Cream VehicleParticipants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
| Part 2: Delgocitinib Cream (Selected Dose) | Experimental | Drug: DelgocitinibParticipants 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. |
| Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose) | Experimental | Drug: Delgocitinib, Drug: Cream VehicleParticipants 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. |
| Part 2: Cream Vehicle | Placebo comparator | Drug: Cream VehicleParticipants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent has been obtained prior to any protocol-related procedures.
- Age ≥18 years at the time of signing informed consent.
- Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
- 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 biopsy. 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 investigational medicinal product (IMP). Participants with newly diagnosed LS can be included, as well as participants who have progressive LS (including existing architectural changes).
Key exclusion criteria (54 listed)
- Participants with atypical presentation of LS in the anogenital area where the diagnosis is uncertain, or the suspicion of malignancy exists.
- Female participants: History of vulvar squamous cell carcinoma (SCC), including precursor lesions (eg, human papillomavirus-independent [HPV-I] vulvar intraepithelial neoplasia [VIN] and high-grade squamous intraepithelial lesion). Male participants: History of penile SCC, including precursor lesions.
- Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV) screening test.
- Active dermatologic or gynecologic conditions that could confound the diagnosis of LS or interfere with assessment of the IMP (eg, urinary incontinence-associated dermatitis, genital lichen planus, and genital psoriasis), as assessed by the investigator.
- Participants with severe urinary incontinence. Incontinence is considered severe if it occurs on most days and more than a few drops at a time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DelgocitinibParticipants will receive delgocitinib BID via topical application. | Drug | Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g, Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g, Part 1: Delgocitinib Cream 20 mg/g, Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle, Part 1: Delgocitinib Cream 8 mg/g, Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle, Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose), Part 2: Delgocitinib Cream (Selected Dose), Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle |
| Cream VehicleParticipants will receive cream vehicle BID via topical administration. | Drug | Part 1: Cream Vehicle, Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g, Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g, Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle, Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle, Part 2: Cream Vehicle, Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose), Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle |
Primary outcome
Number of Participants Achieving IGA-LS TS at Week 12
Time frame: Week 12
18 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Expert study director
LEO Pharma
33 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Delgocitinib in people with Lichen Sclerosus, run by LEO Pharma at 33 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Disclosure ((+45) 4494 5888, disclosure@leo-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Achieving IGA-LS TS at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.