Um Estudo para Saber se o Delgocitinib Pode Ajudar a Reduzir os Sintomas em Pessoas com Líquen Escleroso (DELTA CARE 1)
Um Ensaio de Fase 3, Duplamente Cego, Controlado por Veículo, para Investigar a Eficácia e Segurança da Creme de Delgocitinib Duas Vezes ao Dia em Participantes Adultos com Líquen Escleroso Durante um Período de Tratamento Inicial de 12 Semanas Seguido de um Período de Tratamento de Continuação 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Clinical Disclosure
- Número de telefone: (+45) 4494 5888
- E-mail: disclosure@leo-pharma.com
Locais de estudo
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Manitoba
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Winnipeg, Manitoba, Canadá, R3M 3Z4
- Recrutamento
- LEO Pharma Investigational Site
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New Brunswick
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Fredericton, New Brunswick, Canadá, E3B 1G9
- Recrutamento
- LEO Pharma Investigational Site
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Ontario
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Guelph, Ontario, Canadá, N1L 0B7
- Recrutamento
- LEO Pharma Investigational Site
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Newmarket, Ontario, Canadá, L3Y 2R2
- Recrutamento
- LEO Pharma Investigational Site
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Richmond Hill, Ontario, Canadá, L4E 4L6
- Recrutamento
- LEO Pharma Investigational Site
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Toronto, Ontario, Canadá, M3B 0A7
- Recrutamento
- LEO Pharma Investigational Site
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Toronto, Ontario, Canadá, M4W 2N4
- Recrutamento
- LEO Pharma Investigational Site
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Waterloo, Ontario, Canadá, N2J 1C4
- Recrutamento
- LEO Pharma Investigational Site
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Quebec
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Montreal, Quebec, Canadá, H1Y 3L1
- Recrutamento
- LEO Pharma Investigational Site
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Québec, Quebec, Canadá, G1W 4R4
- Recrutamento
- LEO Pharma Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá, S7K 2C1
- Recrutamento
- LEO Pharma Investigational Site
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Alabama
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Birmingham, Alabama, Estados Unidos, 35244
- Recrutamento
- LEO Pharma Investigational Site
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Recrutamento
- LEO Pharma Investigational Site
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Scottsdale, Arizona, Estados Unidos, 85259
- Recrutamento
- LEO Pharma Investigational Site
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California
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Fremont, California, Estados Unidos, 94538
- Recrutamento
- LEO Pharma Investigational Site
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Connecticut
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Middlebury, Connecticut, Estados Unidos, 06762
- Recrutamento
- LEO Pharma Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20037
- Recrutamento
- LEO Pharma Investigational Site
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Florida
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Boca Raton, Florida, Estados Unidos, 33486
- Recrutamento
- LEO Pharma Investigational Site
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Clearwater, Florida, Estados Unidos, 33756
- Recrutamento
- LEO Pharma Investigational Site
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Jacksonville, Florida, Estados Unidos, 32224
- Recrutamento
- LEO Pharma Investigational Site
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Miami, Florida, Estados Unidos, 33186
- Recrutamento
- LEO Pharma Investigational Site
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Tampa, Florida, Estados Unidos, 33609
- Recrutamento
- LEO Pharma Investigational Site
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Michigan
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Northville, Michigan, Estados Unidos, 48167
- Recrutamento
- LEO Pharma Investigational Site
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- LEO Pharma Investigational Site
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New York
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New York, New York, Estados Unidos, 10036
- Recrutamento
- LEO Pharma Investigational Site
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New York, New York, Estados Unidos, 10029
- Recrutamento
- LEO Pharma Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27516
- Recrutamento
- LEO Pharma Investigational Site
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Ohio
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Bexley, Ohio, Estados Unidos, 43209
- Recrutamento
- LEO Pharma Investigational Site
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Recrutamento
- LEO Pharma Investigational Site
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Recrutamento
- LEO Pharma Investigational Site
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Utah
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Murray, Utah, Estados Unidos, 84107
- Recrutamento
- LEO Pharma Investigational Site
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Liverpool, Reino Unido, L69 3BX
- Recrutamento
- LEO Pharma Investigational Site
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London, Reino Unido, SE1 9RT
- Recrutamento
- LEO Pharma Investigational Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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 Placebo: 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 Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Número de Participantes que Alcançaram IGA-LS TS na Semana 12
Prazo: Semana 12
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Semana 12
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Número de Participantes que Alcançaram IGA-LS TS na Semana 8
Prazo: Semana 8
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Semana 8
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Alteração na Pontuação Clínica de Líquen Escleroso (CLISSCO) desde a Linha de Base até à Semana 12
Prazo: Linha de Base até à Semana 12
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Linha de Base até à Semana 12
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Número de Participantes que Alcançaram uma Redução de ≥4 Pontos na Pontuação da Escala Numérica de Avaliação da Dor Cutânea (NRS) (Média Semanal) desde a Linha de Base até à Semana 12 em Participantes com Pontuação da Linha de Base da Dor Cutânea NRS ≥4
Prazo: Baseline até à Semana 12
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Baseline até à Semana 12
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Número de Participantes que Alcançaram uma Redução da Pontuação NRS de Dor na Pele (Média Semanal) de ≥4 Pontos desde a Linha de Base até à Semana 8 em Participantes com Pontuação NRS de Dor na Pele na Linha de Base ≥4
Prazo: Baseline até à Semana 8
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Baseline até à Semana 8
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Número de Participantes com Redução da Pontuação NRS de Prurido (Média Semanal) de ≥4 Pontos desde a Linha de Base até à Semana 12 em Participantes com Pontuação NRS de Prurido na Linha de Base ≥4
Prazo: Baseline à Semana 12
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Baseline à Semana 12
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Número de Participantes que Alcançaram uma Redução de Pontuação NRS de Comichão (Média Semanal) de ≥4 Pontos desde a Linha de Base até à Semana 8 em Participantes com Pontuação NRS de Comichão na Linha de Base ≥4
Prazo: Baseline até à Semana 8
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Baseline até à Semana 8
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Alteração na Pontuação do Índice de Qualidade de Vida Vulvar (VQLI) desde a Linha de Base até à Semana 12
Prazo: Baseline à Semana 12
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Baseline à Semana 12
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Número de Participantes que Alcançaram IGA-LS TS na Semana 52
Prazo: Semana 52
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Semana 52
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Alteração na Pontuação CLISSCO desde a Linha de Base até à Semana 52
Prazo: Linha de Base até à Semana 52
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Linha de Base até à Semana 52
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Número de Participantes a Alcançar IGA-LS TS na Semana 52 Entre os Participantes que Alcançaram IGA-LS TS na Semana 12
Prazo: Semana 52
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Semana 52
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Número de Participantes que Alcançaram uma Pontuação IGA-LS de 0 ou 1 na Semana 52 Entre os Participantes que Alcançaram IGA-LS TS na Semana 12
Prazo: Semana 52
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Semana 52
|
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Tempo até IGA-LS TS desde a Linha de Base até à Semana 52
Prazo: Baseline até à Semana 52
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Baseline até à Semana 52
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Tempo até IGA-LS ≥2 da Semana 12 à Semana 52 Entre os Participantes que Alcançaram IGA-LS TS na Semana 12
Prazo: Semana 12 até à Semana 52
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Semana 12 até à Semana 52
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Número de Participantes sem Aumento na Pontuação do Domínio de Alterações Arquitetónicas CLISSCO desde a Linha de Base até à Semana 52
Prazo: Do início ao final da Semana 52
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Do início ao final da Semana 52
|
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Número de Participantes que Alcançaram uma Redução da Pontuação NRS da Dor na Pele (Média Semanal) de ≥4 Pontos desde a Linha de Base até à Semana 52 em Participantes com Pontuação NRS da Dor na Pele na Linha de Base ≥4
Prazo: Baseline até à Semana 52
|
Baseline até à Semana 52
|
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Número de Participantes com Redução de Pontuação NRS de Prurido (Média Semanal) de ≥4 Pontos desde a Linha de Base até à Semana 52 em Participantes com Pontuação NRS de Prurido na Linha de Base ≥4
Prazo: Baseline até Semana 52
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Baseline até Semana 52
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Número de Eventos Adversos Emergentes de Tratamento (TEAEs) desde a Linha de Base até à Semana 12
Prazo: Baseline até à Semana 12
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Baseline até à Semana 12
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Número de TEAEs da Semana 12 à Semana 54
Prazo: Semana 12 a Semana 54
|
Semana 12 a Semana 54
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Medical Expert, LEO Pharma
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LP0133-2395
- 2025-524873-17-00 (Ctis)
- U1111-1333-1675 (Outro identificador: World Health Organization (WHO))
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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