Un ensayo para determinar si Delgocitinib puede ayudar a reducir los síntomas en personas con liquen escleroso (DELTA CARE 1)
Un ensayo de fase 3, doble ciego, controlado con vehículo para investigar la eficacia y seguridad de la crema de delgocitinib dos veces al día en participantes adultos con liquen escleroso durante un período de tratamiento inicial de 12 semanas seguido de un período de tratamiento de continuación de 40 semanas
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Disclosure
- Número de teléfono: (+45) 4494 5888
- Correo electrónico: disclosure@leo-pharma.com
Ubicaciones de estudio
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Reclutamiento
- LEO Pharma Investigational Site
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New Brunswick
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Fredericton, New Brunswick, Canadá, E3B 1G9
- Reclutamiento
- LEO Pharma Investigational Site
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Ontario
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Guelph, Ontario, Canadá, N1L 0B7
- Reclutamiento
- LEO Pharma Investigational Site
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Newmarket, Ontario, Canadá, L3Y 2R2
- Reclutamiento
- LEO Pharma Investigational Site
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Richmond Hill, Ontario, Canadá, L4E 4L6
- Reclutamiento
- LEO Pharma Investigational Site
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Toronto, Ontario, Canadá, M3B 0A7
- Reclutamiento
- LEO Pharma Investigational Site
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Toronto, Ontario, Canadá, M4W 2N4
- Reclutamiento
- LEO Pharma Investigational Site
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Waterloo, Ontario, Canadá, N2J 1C4
- Reclutamiento
- LEO Pharma Investigational Site
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Quebec
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Montreal, Quebec, Canadá, H1Y 3L1
- Reclutamiento
- LEO Pharma Investigational Site
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Québec, Quebec, Canadá, G1W 4R4
- Reclutamiento
- LEO Pharma Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7K 2C1
- Reclutamiento
- LEO Pharma Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35244
- Reclutamiento
- LEO Pharma Investigational Site
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Reclutamiento
- LEO Pharma Investigational Site
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Scottsdale, Arizona, Estados Unidos, 85259
- Reclutamiento
- LEO Pharma Investigational Site
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California
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Fremont, California, Estados Unidos, 94538
- Reclutamiento
- LEO Pharma Investigational Site
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Connecticut
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Middlebury, Connecticut, Estados Unidos, 06762
- Reclutamiento
- LEO Pharma Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20037
- Reclutamiento
- LEO Pharma Investigational Site
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Reclutamiento
- LEO Pharma Investigational Site
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Clearwater, Florida, Estados Unidos, 33756
- Reclutamiento
- LEO Pharma Investigational Site
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Jacksonville, Florida, Estados Unidos, 32224
- Reclutamiento
- LEO Pharma Investigational Site
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Miami, Florida, Estados Unidos, 33186
- Reclutamiento
- LEO Pharma Investigational Site
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Tampa, Florida, Estados Unidos, 33609
- Reclutamiento
- LEO Pharma Investigational Site
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Michigan
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Northville, Michigan, Estados Unidos, 48167
- Reclutamiento
- LEO Pharma Investigational Site
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- LEO Pharma Investigational Site
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New York
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New York, New York, Estados Unidos, 10036
- Reclutamiento
- LEO Pharma Investigational Site
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New York, New York, Estados Unidos, 10029
- Reclutamiento
- LEO Pharma Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27516
- Reclutamiento
- LEO Pharma Investigational Site
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Reclutamiento
- LEO Pharma Investigational Site
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Reclutamiento
- LEO Pharma Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Reclutamiento
- LEO Pharma Investigational Site
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Utah
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Murray, Utah, Estados Unidos, 84107
- Reclutamiento
- LEO Pharma Investigational Site
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Liverpool, Reino Unido, L69 3BX
- Reclutamiento
- LEO Pharma Investigational Site
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London, Reino Unido, SE1 9RT
- Reclutamiento
- LEO Pharma Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria
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Signed and dated informed consent has been obtained prior to any protocol-related procedures.
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Age ≥18 years at the time of signing informed consent.
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Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.
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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).
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Disease severity graded as mild to severe at screening and baseline according to IGA-LS score (ie, an IGA-LS score of ≥2).
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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.
Exclusion Criteria
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Participants with atypical presentation of LS in the anogenital area where the diagnosis is uncertain, or the suspicion of malignancy exists.
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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.
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Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV) screening test.
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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.
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Participants with severe urinary incontinence. Incontinence is considered severe if it occurs on most days and more than a few drops at a time.
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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.
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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.
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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.
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Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the trial period.
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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.
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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.
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Known or suspected hypersensitivity to any component(s) of the IMP(s).
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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.
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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.
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Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.
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Female participants only: Women who are pregnant or lactating. For women of childbearing potential, a negative pregnancy test is required at screening.
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Systemic treatment with immunosuppressive drugs (eg, methotrexate, cyclosporine), immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.
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Cutaneously applied treatment with immunomodulators (eg, topical calcineurin inhibitor [TCI]) or topical corticosteroid (TCS) on the anogenital area within 2 weeks before baseline.
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Use of systemic or topical Janus kinase (JAK) inhibitors (including delgocitinib) within 4 weeks before baseline.
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Systemic or cutaneous (applied in the anogenital area) use of antibiotics, antiparasitics, antivirals, or antifungals within 1 week before baseline.
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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.
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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.
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Light-based therapy on the anogenital area and treatments with platelet-rich plasma within 4 weeks prior to baseline.
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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.
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Other cutaneous therapies or therapeutic procedures on the anogenital area within 1 week before baseline.
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Surgical treatment for anogenital LS in the past 6 months or have not recovered fully from an earlier surgical procedure in the anogenital area.
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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).
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Current participation in any other interventional clinical trial.
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Previously randomized in this clinical trial.
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Previously randomized in a clinical trial with delgocitinib.
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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).
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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.
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Participants who are legally institutionalized.
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Only applicable in France: Participant not affiliated with or not a beneficiary of a social security scheme.
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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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Part 1: Delgocitinib Cream 20 mg/g
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. |
Participants will receive delgocitinib BID via topical application. |
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Experimental: Part 1: Delgocitinib Cream 20 mg/g, then Cream Vehicle
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Experimental: Part 1: Delgocitinib Cream 8 mg/g
Participants will receive delgocitinib cream 8 mg/g BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
Participants will receive delgocitinib BID via topical application. |
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Experimental: Part 1: Delgocitinib Cream 8 mg/g, then Cream Vehicle
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Experimental: Part 1: Cream Vehicle, then Delgocitinib Cream 20 mg/g
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Experimental: Part 1: Cream Vehicle, then Delgocitinib Cream 8 mg/g
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Comparador de placebos: Part 1: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
Participants will receive cream vehicle BID via topical administration. |
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Experimental: Part 2: Delgocitinib Cream (Selected Dose)
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. |
Participants will receive delgocitinib BID via topical application. |
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Experimental: Part 2: Delgocitinib Cream (Selected Dose), then Cream Vehicle
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Experimental: Part 2: Cream Vehicle, then Delgocitinib Cream (Selected Dose)
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. |
Participants will receive delgocitinib BID via topical application. Participants will receive cream vehicle BID via topical administration. |
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Comparador de placebos: Part 2: Cream Vehicle
Participants will receive cream vehicle BID in both the 12-week initial treatment period and the 40-week continuation treatment period. |
Participants will receive cream vehicle BID via topical administration. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Número de participantes que lograron IGA-LS TS en la semana 12
Periodo de tiempo: Semana 12
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Semana 12
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Número de participantes que lograron IGA-LS TS en la semana 8
Periodo de tiempo: Semana 8
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Semana 8
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Cambio en la Puntuación Clínica del Liquen Escleroso (CLISSCO) desde el Valor Inicial hasta la Semana 12
Periodo de tiempo: Desde el inicio hasta la semana 12
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Desde el inicio hasta la semana 12
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Número de participantes que lograron una reducción de la puntuación en la escala de valoración numérica (EVN) del dolor cutáneo (promedio semanal) de ≥4 puntos desde el inicio hasta la semana 12 en participantes con una puntuación EVN del dolor cutáneo basal ≥4
Periodo de tiempo: Desde el inicio hasta la semana 12
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Desde el inicio hasta la semana 12
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Número de participantes que lograron una reducción de la puntuación NRS del dolor cutáneo (promedio semanal) de ≥4 puntos desde el inicio hasta la semana 8 en participantes con una puntuación NRS del dolor cutáneo inicial de ≥4
Periodo de tiempo: Del inicio hasta la semana 8
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Del inicio hasta la semana 8
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Número de participantes que lograron una reducción de la puntuación NRS del prurito (promedio semanal) de ≥4 puntos desde el inicio hasta la semana 12 en participantes con puntuación NRS del prurito inicial ≥4
Periodo de tiempo: Desde la línea de base hasta la semana 12
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Desde la línea de base hasta la semana 12
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Número de participantes que alcanzaron una reducción de la puntuación de la EVA del prurito (promedio semanal) de ≥4 puntos desde el inicio hasta la semana 8 en participantes con una puntuación de la EVA del prurito al inicio ≥4
Periodo de tiempo: De la línea base a la semana 8
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De la línea base a la semana 8
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Cambio en la puntuación del Índice de Calidad de Vida Vulvar (VQLI) desde el inicio hasta la semana 12
Periodo de tiempo: Del inicio al final de la semana 12
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Del inicio al final de la semana 12
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Número de participantes que lograron IGA-LS TS en la semana 52
Periodo de tiempo: Semana 52
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Semana 52
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Cambio en la puntuación CLISSCO desde el inicio hasta la semana 52
Periodo de tiempo: Baseline a la Semana 52
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Baseline a la Semana 52
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Número de participantes que lograron IGA-LS TS en la semana 52 entre los participantes que lograron IGA-LS TS en la semana 12
Periodo de tiempo: Semana 52
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Semana 52
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Número de participantes que alcanzaron una puntuación IGA-LS de 0 o 1 en la semana 52 entre los participantes que lograron IGA-LS TS en la semana 12
Periodo de tiempo: Semana 52
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Semana 52
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Tiempo hasta la respuesta TS de IGA-LS desde el inicio hasta la semana 52
Periodo de tiempo: De la línea basal a la semana 52
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De la línea basal a la semana 52
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Tiempo hasta IGA-LS ≥2 desde la semana 12 hasta la semana 52 entre los participantes que lograron IGA-LS TS en la semana 12
Periodo de tiempo: Semana 12 a Semana 52
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Semana 12 a Semana 52
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Número de participantes que no presentan aumento en la puntuación del dominio de cambios arquitectónicos CLISSCO desde el inicio hasta la semana 52
Periodo de tiempo: Desde la línea de base hasta la semana 52
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Desde la línea de base hasta la semana 52
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Número de Participantes que Alcanzaron una Reducción de la Puntuación NRS del Dolor Cutáneo (Promedio Semanal) de ≥4 Puntos desde la Línea de Base hasta la Semana 52 en Participantes con una Puntuación NRS del Dolor Cutáneo en la Línea de Base ≥4
Periodo de tiempo: Desde la línea de base hasta la semana 52
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Desde la línea de base hasta la semana 52
|
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Número de participantes que lograron una reducción de la puntuación de la ENA del prurito (promedio semanal) de ≥4 puntos desde el inicio hasta la semana 52 en participantes con una puntuación de la ENA del prurito en el inicio de ≥4
Periodo de tiempo: Desde el inicio hasta la semana 52
|
Desde el inicio hasta la semana 52
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Número de eventos adversos emergentes del tratamiento (TEAE) desde el inicio hasta la semana 12
Periodo de tiempo: Baseline a la Semana 12
|
Baseline a la Semana 12
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Número de TEAEs desde la semana 12 hasta la semana 54
Periodo de tiempo: Semana 12 a Semana 54
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Semana 12 a Semana 54
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Medical Expert, LEO Pharma
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LP0133-2395
- 2025-524873-17-00 (Ctis)
- U1111-1333-1675 (Otro identificador: World Health Organization (WHO))
- 2025 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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