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Tests treatment safety and results for Lichen Sclerosus
Official title A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus
ClinicalTrials.gov ID: NCT07335588
What this study is testing
What is Delgocitinib?
Delgocitinib is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for lichen sclerosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Disease severity graded as mild to severe at screening and baseline according to IGA-LS score (ie, an IGA-LS score of ≥2).
You likely can't join if
- 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]...
- Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV)...
- Active dermatologic or gynecologic conditions that could confound the diagnosis of LS or interfere with assessment of the IMP (eg, urinary...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Current participation in any other treatment clinical trial.
- Previously assigned by chance in this clinical trial.
- Previously assigned by chance 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Tamarac, Florida, United States
- New York, New York, United States
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Tamarac, Florida, United States; New York, New York, United States; Montreal, Quebec, Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.