이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Delgocitinib이 백선경화증 환자의 증상 완화에 도움이 될 수 있는지 알아보기 위한 임상시험 (DELTA CARE 1)

2026년 10월 12일 업데이트: LEO Pharma

성인 대상자들의 지방 경화증 치료를 위한 12주 초기 치료 기간과 40주 지속 치료 기간 동안, 하루 두 번 델고시티닙 크림의 효능과 안전성을 조사하는 3상, 이중 맹검, 대조군 시험

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

652

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35244
        • 모병
        • LEO Pharma Investigational Site
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • 모병
        • LEO Pharma Investigational Site
      • Scottsdale, Arizona, 미국, 85259
        • 모병
        • LEO Pharma Investigational Site
    • California
      • Fremont, California, 미국, 94538
        • 모병
        • LEO Pharma Investigational Site
    • Connecticut
      • Middlebury, Connecticut, 미국, 06762
        • 모병
        • LEO Pharma Investigational Site
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20037
        • 모병
        • LEO Pharma Investigational Site
    • Florida
      • Boca Raton, Florida, 미국, 33486
        • 모병
        • LEO Pharma Investigational Site
      • Clearwater, Florida, 미국, 33756
        • 모병
        • LEO Pharma Investigational Site
      • Jacksonville, Florida, 미국, 32224
        • 모병
        • LEO Pharma Investigational Site
      • Miami, Florida, 미국, 33186
        • 모병
        • LEO Pharma Investigational Site
      • Tampa, Florida, 미국, 33609
        • 모병
        • LEO Pharma Investigational Site
    • Michigan
      • Northville, Michigan, 미국, 48167
        • 모병
        • LEO Pharma Investigational Site
    • Minnesota
      • Rochester, Minnesota, 미국, 55905
        • 모병
        • LEO Pharma Investigational Site
    • New York
      • New York, New York, 미국, 10036
        • 모병
        • LEO Pharma Investigational Site
      • New York, New York, 미국, 10029
        • 모병
        • LEO Pharma Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27516
        • 모병
        • LEO Pharma Investigational Site
    • Ohio
      • Bexley, Ohio, 미국, 43209
        • 모병
        • LEO Pharma Investigational Site
    • Oregon
      • Portland, Oregon, 미국, 97239
        • 모병
        • LEO Pharma Investigational Site
    • Texas
      • Dallas, Texas, 미국, 75235
        • 모병
        • LEO Pharma Investigational Site
    • Utah
      • Murray, Utah, 미국, 84107
        • 모병
        • LEO Pharma Investigational Site
  • 영국
      • Liverpool, 영국, L69 3BX
        • 모병
        • LEO Pharma Investigational Site
      • London, 영국, SE1 9RT
        • 모병
        • LEO Pharma Investigational Site
  • 캐나다
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3M 3Z4
        • 모병
        • LEO Pharma Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, 캐나다, E3B 1G9
        • 모병
        • LEO Pharma Investigational Site
    • Ontario
      • Guelph, Ontario, 캐나다, N1L 0B7
        • 모병
        • LEO Pharma Investigational Site
      • Newmarket, Ontario, 캐나다, L3Y 2R2
        • 모병
        • LEO Pharma Investigational Site
      • Richmond Hill, Ontario, 캐나다, L4E 4L6
        • 모병
        • LEO Pharma Investigational Site
      • Toronto, Ontario, 캐나다, M3B 0A7
        • 모병
        • LEO Pharma Investigational Site
      • Toronto, Ontario, 캐나다, M4W 2N4
        • 모병
        • LEO Pharma Investigational Site
      • Waterloo, Ontario, 캐나다, N2J 1C4
        • 모병
        • LEO Pharma Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다, H1Y 3L1
        • 모병
        • LEO Pharma Investigational Site
      • Québec, Quebec, 캐나다, G1W 4R4
        • 모병
        • LEO Pharma Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7K 2C1
        • 모병
        • LEO Pharma Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

  1. Signed and dated informed consent has been obtained prior to any protocol-related procedures.

  2. Age ≥18 years at the time of signing informed consent.

  3. Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.

  4. 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).

  5. Disease severity graded as mild to severe at screening and baseline according to IGA-LS score (ie, an IGA-LS score of ≥2).

  6. 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

  1. Participants with atypical presentation of LS in the anogenital area where the diagnosis is uncertain, or the suspicion of malignancy exists.

  2. 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.

  3. Female participants only: Participants with any abnormal cytology result at screening following a positive high-risk human papillomavirus (hrHPV) screening test.

  4. 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.

  5. Participants with severe urinary incontinence. Incontinence is considered severe if it occurs on most days and more than a few drops at a time.

  6. 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.

  7. 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.

  8. 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.

  9. Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalization during the trial period.

  10. 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.

  11. 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.

  12. Known or suspected hypersensitivity to any component(s) of the IMP(s).

  13. 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.

  14. 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.

  15. Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.

  16. Female participants only: Women who are pregnant or lactating. For women of childbearing potential, a negative pregnancy test is required at screening.

  17. Systemic treatment with immunosuppressive drugs (eg, methotrexate, cyclosporine), immunomodulating drugs, retinoids, or corticosteroids within 4 weeks prior to baseline.

  18. Cutaneously applied treatment with immunomodulators (eg, topical calcineurin inhibitor [TCI]) or topical corticosteroid (TCS) on the anogenital area within 2 weeks before baseline.

  19. Use of systemic or topical Janus kinase (JAK) inhibitors (including delgocitinib) within 4 weeks before baseline.

  20. Systemic or cutaneous (applied in the anogenital area) use of antibiotics, antiparasitics, antivirals, or antifungals within 1 week before baseline.

  21. 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.

  22. 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.

  23. Light-based therapy on the anogenital area and treatments with platelet-rich plasma within 4 weeks prior to baseline.

  24. 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.

  25. Other cutaneous therapies or therapeutic procedures on the anogenital area within 1 week before baseline.

  26. Surgical treatment for anogenital LS in the past 6 months or have not recovered fully from an earlier surgical procedure in the anogenital area.

  27. 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).

  28. Current participation in any other interventional clinical trial.

  29. Previously randomized in this clinical trial.

  30. Previously randomized in a clinical trial with delgocitinib.

  31. 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).

  32. 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.

  33. Participants who are legally institutionalized.

  34. Only applicable in France: Participant not affiliated with or not a beneficiary of a social security scheme.

  35. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
위약 비교기: 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.
의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
실험적: 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.
의약품: Delgocitinib

Participants will receive delgocitinib BID via topical application.

의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.
위약 비교기: 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.
의약품: Cream Vehicle

Participants will receive cream vehicle BID via topical administration.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
12주차 IGA-LS TS 달성 참가자 수
기간: 12주차
12주차

2차 결과 측정

결과 측정
기간
참가자 중 8주차에 IGA-LS TS를 달성한 참가자 수
기간: 8주차
8주차
기저선 대비 12주간의 임상 이끼 경화증 점수(CLISSCO) 변화
기간: 기저선부터 12주차까지
기저선부터 12주차까지
기저선 피부 통증 NRS 점수 ≥4인 참가자에서 기저선부터 12주까지 주간 평균 피부 통증 NRS 점수가 ≥4점 감소한 참가자 수
기간: 기준점부터 12주까지
기준점부터 12주까지
기초선 피부 통증 NRS 점수가 ≥4점인 참가자에서 기초선부터 8주차까지 주간 평균 피부 통증 NRS 점수가 ≥4점 이상 감소한 참가자 수
기간: 기준선부터 8주차까지
기준선부터 8주차까지
기저선 가려움 NRS 점수가 ≥4점인 참가자에서 기저선 대비 12주차까지 가려움 NRS 점수(주간 평균)가 ≥4점 감소한 참가자 수
기간: 기준점부터 12주까지
기준점부터 12주까지
기저선 가려움증 NRS 점수 ≥4점인 참가자에서 기저선부터 8주차까지 가려움증 NRS 점수(주간 평균)가 ≥4점 감소한 참가자 수
기간: 기저선부터 8주차까지
기저선부터 8주차까지
기저선 대비 12주차의 외음부 삶의 질 지수(VQLI) 점수 변화
기간: 기준 시점부터 12주까지
기준 시점부터 12주까지
52주차 IGA-LS TS 달성 참가자 수
기간: 52주
52주
기준선부터 52주차까지의 CLISSCO 점수 변화
기간: 기준 시점부터 52주까지
기준 시점부터 52주까지
주 12에 IGA-LS TS를 달성한 참가자 중 주 52에 IGA-LS TS를 달성한 참가자 수
기간: 52주차
52주차
주 12에 IGA-LS TS를 달성한 참가자 중 주 52에 IGA-LS 점수 0 또는 1을 달성한 참가자 수
기간: 52주
52주
기준선부터 52주차까지의 IGA-LS TS 도달 시간
기간: 기저선부터 52주까지
기저선부터 52주까지
주 12부터 주 52까지 IGA-LS 점수 ≥2 도달 시간 (주 12에 IGA-LS TS를 달성한 참가자 대상)
기간: 12주차부터 52주차까지
12주차부터 52주차까지
기준 시점부터 52주차까지 CLISSCO 구조 변화 도메인 점수가 증가하지 않은 참가자 수
기간: 베이스라인부터 52주까지
베이스라인부터 52주까지
기준선 피부 통증 NRS 점수 ≥4점인 참가자에서 기준선부터 52주까지 피부 통증 NRS 점수(주간 평균)가 ≥4점 감소한 참가자 수
기간: 기저선부터 52주까지
기저선부터 52주까지
기저선 가려움증 NRS 점수가 ≥4점인 참가자에서 기저선부터 52주차까지 가려움증 NRS 점수(주간 평균)가 ≥4점 감소한 참가자 수
기간: 기준 시점부터 52주까지
기준 시점부터 52주까지
기저선부터 12주차까지 발생한 치료 관련 이상반응(TEAEs) 건수
기간: 베이스라인부터 12주까지
베이스라인부터 12주까지
제12주부터 제54주까지의 TEAE 발생 건수
기간: 12주차부터 54주차까지
12주차부터 54주차까지

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

LEO Pharma

수사관

  • 연구 책임자: Medical Expert, LEO Pharma

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 1일

기본 완료 (추정된)

2028년 3월 10일

연구 완료 (추정된)

2028년 12월 29일

연구 등록 날짜

최초 제출

2026년 1월 9일

QC 기준을 충족하는 최초 제출

2026년 1월 9일

처음 게시됨 (실제)

2026년 1월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 12일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LP0133-2395
  • 2025-524873-17-00 (씨티스)
  • U1111-1333-1675 (기타 식별자: World Health Organization (WHO))
  • 2025 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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