Et forsøk for å finne ut om Delgocitinib kan hjelpe med å redusere symptomer hos personer med lichen sclerosus (DELTA CARE 1)
En fase 3, dobbeltblind, kjøretøyskontrollert studie for å undersøke effektiviteten og sikkerheten av Delgocitinib krem to ganger daglig hos voksne deltakere med lichen sclerosus under en 12-ukers initial behandlingsperiode etterfulgt av en 40-ukers videre behandlingsperiode
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Disclosure
- Telefonnummer: (+45) 4494 5888
- E-post: disclosure@leo-pharma.com
Studiesteder
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Manitoba
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Winnipeg, Manitoba, Canada, R3M 3Z4
- Rekruttering
- LEO Pharma Investigational Site
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New Brunswick
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Fredericton, New Brunswick, Canada, E3B 1G9
- Rekruttering
- LEO Pharma Investigational Site
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Ontario
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Guelph, Ontario, Canada, N1L 0B7
- Rekruttering
- LEO Pharma Investigational Site
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Newmarket, Ontario, Canada, L3Y 2R2
- Rekruttering
- LEO Pharma Investigational Site
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Richmond Hill, Ontario, Canada, L4E 4L6
- Rekruttering
- LEO Pharma Investigational Site
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Toronto, Ontario, Canada, M3B 0A7
- Rekruttering
- LEO Pharma Investigational Site
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Toronto, Ontario, Canada, M4W 2N4
- Rekruttering
- LEO Pharma Investigational Site
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Waterloo, Ontario, Canada, N2J 1C4
- Rekruttering
- LEO Pharma Investigational Site
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Quebec
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Montreal, Quebec, Canada, H1Y 3L1
- Rekruttering
- LEO Pharma Investigational Site
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Québec, Quebec, Canada, G1W 4R4
- Rekruttering
- LEO Pharma Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 2C1
- Rekruttering
- LEO Pharma Investigational Site
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Alabama
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Birmingham, Alabama, Forente stater, 35244
- Rekruttering
- LEO Pharma Investigational Site
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Rekruttering
- LEO Pharma Investigational Site
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Scottsdale, Arizona, Forente stater, 85259
- Rekruttering
- LEO Pharma Investigational Site
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California
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Fremont, California, Forente stater, 94538
- Rekruttering
- LEO Pharma Investigational Site
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Connecticut
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Middlebury, Connecticut, Forente stater, 06762
- Rekruttering
- LEO Pharma Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20037
- Rekruttering
- LEO Pharma Investigational Site
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Florida
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Boca Raton, Florida, Forente stater, 33486
- Rekruttering
- LEO Pharma Investigational Site
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Clearwater, Florida, Forente stater, 33756
- Rekruttering
- LEO Pharma Investigational Site
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Jacksonville, Florida, Forente stater, 32224
- Rekruttering
- LEO Pharma Investigational Site
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Miami, Florida, Forente stater, 33186
- Rekruttering
- LEO Pharma Investigational Site
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Tampa, Florida, Forente stater, 33609
- Rekruttering
- LEO Pharma Investigational Site
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Michigan
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Northville, Michigan, Forente stater, 48167
- Rekruttering
- LEO Pharma Investigational Site
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- LEO Pharma Investigational Site
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New York
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New York, New York, Forente stater, 10036
- Rekruttering
- LEO Pharma Investigational Site
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New York, New York, Forente stater, 10029
- Rekruttering
- LEO Pharma Investigational Site
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27516
- Rekruttering
- LEO Pharma Investigational Site
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Ohio
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Bexley, Ohio, Forente stater, 43209
- Rekruttering
- LEO Pharma Investigational Site
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Oregon
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Portland, Oregon, Forente stater, 97239
- Rekruttering
- LEO Pharma Investigational Site
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Texas
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Dallas, Texas, Forente stater, 75235
- Rekruttering
- LEO Pharma Investigational Site
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Utah
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Murray, Utah, Forente stater, 84107
- Rekruttering
- LEO Pharma Investigational Site
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Liverpool, Storbritannia, L69 3BX
- Rekruttering
- LEO Pharma Investigational Site
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London, Storbritannia, SE1 9RT
- Rekruttering
- LEO Pharma Investigational Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Placebo komparator: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Placebo komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antall deltakere som oppnår IGA-LS TS ved uke 12
Tidsramme: Uke 12
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Uke 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Antall deltakere som oppnår IGA-LS TS uke 8
Tidsramme: Uke 8
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Uke 8
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Endring i Clinical Lichen Sclerosus Score (CLISSCO) fra baseline til uke 12
Tidsramme: Baseline til uke 12
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Baseline til uke 12
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Antall deltakere som oppnår en reduksjon i Skin Pain Numerical Rating Scale (NRS)-score (ukentlig gjennomsnitt) på ≥4 poeng fra baseline til uke 12 hos deltakere med baseline Skin Pain NRS-score ≥4
Tidsramme: Baseline til uke 12
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Baseline til uke 12
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Antall deltakere som oppnår en reduksjon i hudsmerteskår på NRS-skalaen (ukentlig gjennomsnitt) på ≥4 poeng fra baseline til uke 8 hos deltakere med baseline hudsmerteskår på NRS-skalaen ≥4
Tidsramme: Baseline til uke 8
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Baseline til uke 8
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Antall deltakere som oppnår en reduksjon i kløe NRS-skår (ukentlig gjennomsnitt) på ≥4 poeng fra baseline til uke 12 hos deltakere med baseline kløe NRS-skår ≥4
Tidsramme: Baseline til uke 12
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Baseline til uke 12
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Antall deltakere som oppnådde en reduksjon i kløe NRS-skår (ukentlig gjennomsnitt) på ≥4 poeng fra baseline til uke 8 hos deltakere med baseline kløe NRS-skår ≥4
Tidsramme: Baseline til uke 8
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Baseline til uke 8
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Endring i Vulvar Livskvalitetsindeks (VQLI) poengsum fra baseline til uke 12
Tidsramme: Baseline til uke 12
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Baseline til uke 12
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Antall deltakere som oppnådde IGA-LS TS ved uke 52
Tidsramme: Uke 52
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Uke 52
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Endring i CLISSCO-skår fra baseline til uke 52
Tidsramme: Baseline til uke 52
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Baseline til uke 52
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Antall deltakere som oppnår IGA-LS TS ved uke 52 blant deltakere som har oppnådd IGA-LS TS ved uke 12
Tidsramme: Uke 52
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Uke 52
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Antall deltakere som oppnår en IGA-LS-score på 0 eller 1 ved uke 52 blant deltakere som hadde oppnådd IGA-LS TS ved uke 12
Tidsramme: Uke 52
|
Uke 52
|
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Tid til IGA-LS TS fra baseline til uke 52
Tidsramme: Baseline til uke 52
|
Baseline til uke 52
|
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Tid til IGA-LS ≥2 fra uke 12 til uke 52 blant deltakere som oppnådde IGA-LS TS ved uke 12
Tidsramme: Uke 12 til uke 52
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Uke 12 til uke 52
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Antall deltakere som ikke har økning i CLISSCO Architectural Changes-domene poengsum fra baseline til uke 52
Tidsramme: Baseline til uke 52
|
Baseline til uke 52
|
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Antall deltakere som oppnår en reduksjon i hudsmerteskår på NRS (ukentlig gjennomsnitt) på ≥4 poeng fra baseline til uke 52 hos deltakere med baseline hudsmerteskår på NRS ≥4
Tidsramme: Fra baseline til uke 52
|
Fra baseline til uke 52
|
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Antall deltakere som oppnår en reduksjon i kløe NRS-skår (ukentlig gjennomsnitt) på ≥4 poeng fra utgangspunktet til uke 52 hos deltakere med utgangspunkt kløe NRS-skår ≥4
Tidsramme: Baseline til uke 52
|
Baseline til uke 52
|
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Antall behandlingsrelaterte bivirkninger (TEAE) fra baseline til uke 12
Tidsramme: Fra baseline til uke 12
|
Fra baseline til uke 12
|
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Antall TEAE-er fra uke 12 til uke 54
Tidsramme: Uke 12 til uke 54
|
Uke 12 til uke 54
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Expert, LEO Pharma
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LP0133-2395
- 2025-524873-17-00 (Ctis)
- U1111-1333-1675 (Annen identifikator: World Health Organization (WHO))
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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