- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06602219
중등도~중증 판상 건선 성인 참가자를 대상으로 한 LY4100511(Dice 853)의 2상 용량 범위 연구
중등도~중증 판상 건선 성인 참가자의 치료를 위한 LY4100511(DC-853)의 2상, 다기관, 무작위 배정, 이중 맹검, 위약 대조, 병렬 그룹, 용량 범위 연구
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Dresden, 독일, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Hamburg, 독일, 22391
- MensingDerma Research GmbH
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Baden-Wurttemberg
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Tübingen, Baden-Wurttemberg, 독일, 72076
- Universitatsklinikum Tubingen
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Bavaria
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Augsburg, Bavaria, 독일, 86150
- Praxis Dr. med. Virgil-Oreste Mihaescu Facharzt fr Dermatologie und STD
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Hesse
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Frankfurt am Main, Hesse, 독일, 60590
- Universitätsklinikum Frankfurt
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, 독일, 48149
- Universitätsklinikum Münster
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Alabama
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Birmingham, Alabama, 미국, 35244
- Cahaba Dermatology Skin Health Center
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Arkansas
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Bryant, Arkansas, 미국, 72022
- Dermatology Trial Associates
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California
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Beverly Hills, California, 미국, 90212
- Zenith Research, Inc.
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Fountain Valley, California, 미국, 92708
- First OC Dermatology Research Inc
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Fremont, California, 미국, 94538-1614
- Center for Dermatology Clinical Research
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Los Angeles, California, 미국, 90045
- Dermatology Research Associates
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Santa Monica, California, 미국, 90404
- Clinical Science Institute
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Florida
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Coral Gables, Florida, 미국, 33134
- Driven Research
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Hialeah, Florida, 미국, 33012
- Direct Helpers Research Center
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Ocala, Florida, 미국, 34470
- Renstar Medical Research
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St. Petersburg, Florida, 미국, 33713-8012
- GCP Global Clinical Professionals, LLC
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Tampa, Florida, 미국, 33613
- ForCare Clinical Research
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Illinois
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Skokie, Illinois, 미국, 60077-1049
- Endeavor Clinical Trials Center - Dermatology - Skokie
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Maryland
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Rockville, Maryland, 미국, 20850
- Lawrence J Green, M.D, LLC
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Texas
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Webster, Texas, 미국, 77598
- Center for Clinical Studies, LTD.LLP
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Tokyo, 일본
- Igarashi Dermatological Clinic
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Aichi-ken
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Nagoya, Aichi-ken, 일본, 450-0003
- Nagoya City University Hospital
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Hakkaido
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Sapporo, Hakkaido, 일본, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, 일본, 890-0063
- Katahira Dermatology Urology Clinic
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Kumamoto
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Kumamoto, Kumamoto, 일본, 861-4101
- Ohyama Dermatology Clinic
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Osaka
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Sakai-shi, Osaka, 일본, 593-8324
- Kume Clinic
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Tokyo
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Shinjuku-ku, Tokyo, 일본, 160-0023
- Tokyo Medical University Hospital
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Tachikawa, Tokyo, 일본, 190-0023
- Tachikawa Dermatology Clinic
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Toyama
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Takaoka, Toyama, 일본, 933-0871
- Shirasaki dermatology clinic
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Pardubice, 체코, 530 02
- Pratia Pardubice a.s. - PRATIA - PPDS
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Prague, 체코, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, 체코, 13000
- Pratia Prague s.r.o. - PRATIA - PPDS
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Prague, 체코, 160 00
- Kozni ambulance Fialova, s.r.o. - CRC - PPDS
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Praha 10
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Prague, Praha 10, 체코, 10100
- CLINTRIAL s.r.o.
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British Columbia
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Kelowna, British Columbia, 캐나다, V1W 4V5
- Interior Dermatology Centre - Probity - PPDS
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Nanaimo, British Columbia, 캐나다, V9T1W1
- Skin Care West
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Ontario
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Barrie, Ontario, 캐나다, L4M 7G1
- Simcoderm Medical & Surgical Dermatology Centre
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Hamilton, Ontario, 캐나다, L8N 1Y2
- Dermatrials Research Inc.
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London, Ontario, 캐나다, N6H 5L5
- DermEffects - Probity - PPDS
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London, Ontario, 캐나다, N6A 5R9
- Lovegrove Dermatology - Probity - PPDS
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Markham, Ontario, 캐나다, L3P 1X2
- Lynderm Research Inc.
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Mississauga, Ontario, 캐나다, L4Y 4C5
- DermEdge Research
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Katowice, 폴란드, 40-611
- Centrum Medyczne Angelius Provita
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Warsaw, 폴란드, 02-665
- Centrum Medyczne Reuma Park NZOZ
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-566
- Cityclinic Przychodnia Lekarsko Psychologiczna Matusiak Spółka Partnerska
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Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-381
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 00-710
- Clinical Best Solutions
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, 폴란드, 35-055
- Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, 폴란드, 80-382
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
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Gdynia, Pomeranian Voivodeship, 폴란드, 81-537
- AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni
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Silesian Voivodeship
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Częstochowa, Silesian Voivodeship, 폴란드, 42-202
- Synexus Polska Sp. z o.o. Oddzial w Czestochowie
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, 폴란드, 70-332
- Laser Clinic Dermatologia Laserowa Medycyna Estetyczna
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, 폴란드, 90-436
- Dermoklinika Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
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Gyöngyös, 헝가리, 3200
- Gyongyosi Bugat Pal Korhaz
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Veszprém, 헝가리, 8200
- MedMare Bt
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
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Jász-Nagykun-Szolnok
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Szolnok, Jász-Nagykun-Szolnok, 헝가리, 5000
- Allergo-Derm Bakos Kft
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 기준일 1일 무작위 배정 전 6개월 동안 판상 건선의 임상 진단
- 체질량지수(BMI)가 18~40kg/제곱미터(kg/m2)(포함)여야 합니다.
- 첫 번째 연구 개입 전에 건선에 대한 국소 및/또는 전신 요법을 기꺼이 중단해야 합니다.
- 연구 중 태양에 장기간 노출을 피하고 선탠 부스, 태양 램프 및 기타 자외선 광원의 사용을 삼가는 데 동의해야 합니다.
제외 기준:
- 조사자가 평가한 바와 같이, 기준선 전 12주 동안 임상적으로 유의미한 건선 발적이 나타났습니다.
- 홍피성 건선, 전신성 또는 국소성 농포성 건선, 주로 창상 건선, 약물 유발 또는 약물 악화 건선의 병력이 있는 경우.
- 류마티스 관절염, 유육종증, IBD(크론병 또는 궤양성 대장염) 또는 전신성 홍반성 루푸스를 포함하되 이에 국한되지 않는 건선 및 건선성 관절염 이외의 염증성 질환에 대해 알려졌거나 의심되는 진단을 받은 경우.
- 전신 면역억제제 치료(코르티코스테로이드, 면역억제제, 생물학적 제제 포함)가 필요하거나 현재 치료를 받고 있는 건선성 관절염 진단을 받은 경우.
- 현재 또는 최근 급성 활동성 감염이 있는 경우. 참가자는 감염이 확인되거나 의심되는 증상이나 징후가 없어야 하며 선별검사 전 최소 30일 동안 무작위 배정/기준선까지 적절한 항감염 치료를 완료해야 합니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: LY4100511 200 mg BID
Participants received LY4100511 200 milligrams (mg) administered orally twice daily (BID) for 12 weeks.
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구두로 관리
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실험적: LY4100511 400 mg BID
Participants received LY4100511 400 mg administered orally BID for 12 weeks.
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구두로 관리
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실험적: LY4100511 800 mg QD
Participants received LY4100511 800 mg administered orally once daily (QD) for 12 weeks, with matching placebo administered in the evening.
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구두로 관리
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위약 비교기: Placebo BID
Participants received placebo administered orally BID for 12 weeks.
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구두로 관리
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 Versus Placebo)
기간: Week 12
|
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 (LY4100511 200mg vs 400mg vs 800mg)
기간: Week 12
|
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
|
Percentage of Participants Achieving an sPGA Score of 0 (Clear) or 1 (Almost Clear) With ≥2 Grade Improvement From Baseline at Week 12
기간: Week 12
|
Percentage of participants achieving a static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with ≥2-grade improvement from baseline at Week 12. The investigator assessed psoriasis severity on a 5-point scale from 0 (clear) to 4 (severe):
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Week 12
|
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Percentage of Participants Achieving ≥50% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-50) at Week 12
기간: Week 12
|
Percentage of participants achieving ≥50% reduction from baseline in PASI-50 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
|
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
기간: Week 12
|
Percentage of participants achieving ≥75% reduction from baseline in PASI-75 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
|
Percentage of Participants Achieving ≥90% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-90) at Week 12
기간: Week 12
|
Percentage of participants achieving ≥90% reduction from baseline in PASI-90 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
|
Percentage of Participants Achieving ≥100% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-100) at Week 12
기간: Week 12
|
Percentage of participants achieving ≥100% reduction from baseline in PASI-100 at Week 12 without use of background antipsoriasis therapy were responders.
The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected.
Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs.
Area involvement in each region is graded from 0 (none) to 6 (90-100%).
The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4).
Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity.
|
Week 12
|
|
Change From Baseline in PASI Score at Week 12
기간: Baseline, Week 12
|
Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. |
Baseline, Week 12
|
|
Percent Change From Baseline in PASI Score at Week 12
기간: Baseline, Week 12
|
Least square mean was determined with mixed model repeated measures (MMRM) using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline PASI score, prior biologic therapy (Yes/No), and geographic region as fixed effects. The PASI measures psoriasis severity based on lesion characteristics and body surface area (BSA) affected. Erythema, thickness, and scaling are each scored from 0 (none) to 4 (very severe) across four regions: head, trunk, upper limbs, and lower limbs. Area involvement in each region is graded from 0 (none) to 6 (90-100%). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and a region-specific BSA weight (0.1, 0.3, 0.2, 0.4). Regional scores are summed to give a total PASI score ranging from 0 to 72, with higher values indicating greater severity. |
Baseline, Week 12
|
|
Change From Baseline in the Percentage of Body Surface Area (BSA) Affected at Week 12
기간: Baseline, Week 12
|
Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value. BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement. |
Baseline, Week 12
|
|
Percent Change From Baseline in the Percentage of BSA Affected at Week 12
기간: Baseline, Week 12
|
Least square mean was determined with MMRM using an unstructured covariance matrix, including treatment, visit, treatment-by-visit interaction, baseline BSA, prior biologic therapy (Yes/No), geographic region, and baseline BMI, baseline is the last non-missing pre-dose value. BSA is a measurement of the affected skin area. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). The overall BSA affected by psoriasis plaques is estimated based on the palm area of the participant hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total BSA. Negative change from baseline indicates improvement. |
Baseline, Week 12
|
|
Pharmacokinetics (PK): Steady State Maximum Concentration of LY4100511 (Cmax,ss)
기간: Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
|
Steady State Maximum Concentration of LY4100511 (Cmax,ss) is reported.
|
Day 1: Predose, 0.5, 1 hours postdose; Day 15: Predose, 0.5, 1, 4 hours postdose; Day 57: Predose, 0.5, 1, 4 hours postdose
|
|
Pharmacokinetics (PK): Steady State Trough Concentration (Ctrough,ss) of LY4100511
기간: Predose at Day 8, 15, 29, 57 and 85
|
Ctrough,ss of LY4100511
|
Predose at Day 8, 15, 29, 57 and 85
|
|
Number of Participants With TEAEs and SAEs Observed During the Study of LY4100511
기간: Baseline up to Week 12
|
The number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) observed during the study of LY4100511. A TEAE is defined as an AE that occurs during or after the first study drug administration and up to and including the follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence at any dose that:
|
Baseline up to Week 12
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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