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낮은 체표면적 중등도 판상 건선 치료를 위한 구셀쿠맙 대 위약에 대한 연구 (SPECTREM)

2026년 4월 10일 업데이트: Janssen Research & Development, LLC

특수 부위를 포함하는 저체표면적(BSA) 중등도 판상 건선 치료에 대한 구셀쿠맙과 위약의 안전성과 유효성을 평가하는 3b상, 다기관, 무작위, 이중 맹검, 위약 대조 연구

이 연구의 목적은 낮은 체표면적 중등도 판상 건선 및 특수 부위 침범이 있는 참가자를 대상으로 비활성 약물과 비교하여 구셀쿠맙의 효능을 평가하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

338

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35244
        • Cahaba Research Inc
      • Birmingham, Alabama, 미국, 35203
        • Total Dermatology
    • California
      • Encinitas, California, 미국, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, 미국, 92708
        • First OC Dermatology
      • Riverside, California, 미국, 92505
        • Practice Wang
      • San Diego, California, 미국, 92123
        • Therapeutics Clinical Research
      • Santa Ana, California, 미국, 92701
        • Rehlen, Bartlow, Goodman and Baron Dermatology Group
      • Santa Monica, California, 미국, 90404
        • Clinical Science Institute
    • Connecticut
      • Farmington, Connecticut, 미국, 06030
        • University of Conn Health Center
    • Florida
      • Brandon, Florida, 미국, 33511
        • TrueBlue Clinical Research
      • Coral Gables, Florida, 미국, 33134
        • Florida Academic Dermatology Centers
      • Doral, Florida, 미국, 33122
        • Revival Research
      • Margate, Florida, 미국, 33063
        • Glick Research Institute
      • Miami, Florida, 미국, 33124
        • Miami VA Healthcare System
      • North Miami Beach, Florida, 미국, 33162
        • Tory P Sullivan M D PA
    • Georgia
      • Atlanta, Georgia, 미국, 303331
        • Atlanta Biomedical Clinical Research
    • Maryland
      • Columbia, Maryland, 미국, 21045
        • Kindred Hair and Skin Center
      • Rockville, Maryland, 미국, 20850
        • DermAssociates, PC
      • Rockville, Maryland, 미국, 20850
        • Lawrence J Green MD LLC
    • Massachusetts
      • Brighton, Massachusetts, 미국, 02135
        • Metro Boston Clinical Partners
      • Quincy, Massachusetts, 미국, 02169
        • DermCare, LLC
    • Michigan
      • West Bloomfield, Michigan, 미국, 48322
        • Henry Ford Medical Center
    • New York
      • New York, New York, 미국, 10003
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, 미국, 10128
        • Markowitz Medical OptiSkin
    • North Carolina
      • Cary, North Carolina, 미국, 27511
        • Accellacare Research of Cary
      • Charlotte, North Carolina, 미국, 28277
        • Darst Dermatology
      • Huntersville, North Carolina, 미국, 28078
        • Piedmont Plastic Surgery and Dermatology
    • Ohio
      • Bexley, Ohio, 미국, 43209
        • Bexley Dermatology Research
      • Columbus, Ohio, 미국, 43215
        • Remington Davis Inc
      • Mayfield Heights, Ohio, 미국, 44124
        • Apex Dermatology Mayfield Heights
    • South Carolina
      • Charleston, South Carolina, 미국, 29414
        • Dermatology and Laser Center of Charleston
      • Fountain Inn, South Carolina, 미국, 29644
        • Palmetto Clinical Trial Services, LLC
    • Tennessee
      • Nashville, Tennessee, 미국, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, 미국, 37212
        • Nashville Skin: Comprehensive Dermatology Center
    • Texas
      • Arlington, Texas, 미국, 76011
        • Arlington Center for Dermatology
      • Bellaire, Texas, 미국, 77401
        • Bellair Dermatology
      • Dallas, Texas, 미국, 75231
        • Modern Research Associates PLLC
      • Dallas, Texas, 미국, 75246
        • Menter Dermatology Research Institute
      • Dallas, Texas, 미국, 75235
        • Bare Dermatology
      • Houston, Texas, 미국, 77004
        • Center for Clinical Studies
      • Houston, Texas, 미국, 77056-4132
        • Suzanne Bruce and Associates - The Center for Skin Research
      • San Antonio, Texas, 미국, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, 미국, 78218
        • Texas Dermatology and Laser Specialists
      • Sugar Land, Texas, 미국, 77479
        • Acclaim Dermatology
    • Washington
      • Mill Creek, Washington, 미국, 98102
        • Frontier Derm Partners CRO, LLC
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T3E 0B2
        • Beacon Dermatology
      • Edmonton, Alberta, 캐나다, T5J 3S9
        • Rejuvenation Dermatology Clinic Edmonton Downtown
    • British Columbia
      • Surrey, British Columbia, 캐나다, V3V 0C6
        • Enverus Medical
      • Surrey, British Columbia, 캐나다, V3R 6A7
        • Dr. Chih ho Hong Medical
    • Manitoba
      • Winnipeg, Manitoba, 캐나다, R3M 3Z4
        • Wiseman Dermatology Research Inc.
      • Winnipeg, Manitoba, 캐나다, R3C 0N2
        • Winnipeg Clinic
    • New Brunswick
      • Fredericton, New Brunswick, 캐나다, E3B 1G9
        • Brunswick Dermatology Center
    • Ontario
      • Ajax, Ontario, 캐나다, L1S7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, 캐나다, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, 캐나다, L8N 1Y2
        • Dermatrials Research
      • London, Ontario, 캐나다, N6H 5L5
        • Dr Wei Jing Loo Medicine Professional Corporation
      • North York, Ontario, 캐나다, M2M 4J5
        • North York Research Inc
      • Ottawa, Ontario, 캐나다, K1H 7X3
        • JRB Research Inc
      • Toronto, Ontario, 캐나다, M4W 2N2
        • Research Toronto
      • Toronto, Ontario, 캐나다, M3H 5Y8
        • Toronto Research Centre
      • Toronto, Ontario, 캐나다, M3B 0A7
        • Canadian Dermatology Center
      • Toronto, Ontario, 캐나다, M4E 2Y9
        • FACET Dermatology
      • Waterloo, Ontario, 캐나다, N2J 1C4
        • K. Papp Clinical Research Inc.
    • Quebec
      • Québec, Quebec, 캐나다, G1W 4R4
        • The Centre de recherche Saint-Louis

참여기준

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

자격 기준

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아니

설명

포함 기준:

  • 모든 참가자는 연구 개입을 처음 실시하기 전 최소 6개월 동안 판상 건선(건선성 관절염 유무와 관계없이) 진단을 받아야 합니다.
  • 모든 참가자는 스크리닝 및 기준선에서 다음과 같은 질병 중증도 기준을 충족해야 합니다: (a) 종합 조사자의 종합 평가(IGA) 3(중등도) 판상 건선; (b) 신체 표면적(BSA) 2-15%(%), 특수 부위 외부에 최소 1개의 플라크가 있음; (c) 중등도 이상의 심각도를 갖는 최소 1개의 특수 부위가 관련되어 있습니다. 적격 부위에는 두피 특정 IGA가 3 이상(>=)인 두피, 안면 건선 IGA >=3인 얼굴, 간질성 건선 IGA >=3인 간질성 또는 정적인 의사의 생식기 종합 평가(sPGA-)가 있는 생식기가 포함됩니다. G) >=3
  • 모든 참가자는 최소 1가지 이전 국소 요법(코르티코스테로이드, 레티노이드, 비타민 D 또는 비타민 D/스테로이드 및 레티노이드/스테로이드 조합, 타크로리무스, 피메크롤리무스, 안트랄린/디트라놀, 석탄을 포함하되 이에 국한되지 않음)으로 부적절하게 조절되거나 내약성이 없습니다. 두 스크리닝 모두에서 건선 치료를 위한 타르 제제, 타피나로프, 로플루밀라스트 등)
  • 모든 참가자는 건선에 대한 광선 요법 또는 전신 치료의 후보자입니다.

제외 기준:

  • 스크리닝 또는 무작위 배정 시 판상이 아닌 형태의 건선(예: 홍피성 건선, 소화성 건선 또는 농포성)이 있는 경우
  • 현재 약물 유발 건선이 있는 경우(예: 건선이 새로 발병하거나 베타 차단제, 칼슘 채널 차단제 또는 리튬으로 인해 건선이 악화됨)
  • 손발바닥 침범이 있는 참가자의 경우, 손발바닥 농포증, 습진성 피부염, 접촉/자극성 피부염, 후천성 각피증 등을 포함하되 이에 국한되지 않는 혼란스러운 진단을 확인하고 제외해야 합니다.
  • 건선, 건선 관절염(PsA) 또는 건선 평가에 영향을 미칠 수 있는 기타 적응증 치료를 위해 이전에 생물학적 제제(또는 바이오시밀러)를 받은 적이 있는 참가자는 자격이 없습니다. 이전 생물학적 제제(또는 바이오시밀러)에는 종양괴사인자(TNF) 억제제(예: 아달리무맙, 에타네르셉트, 인플릭시맙 또는 세르톨리주맙 또는 바이오시밀러), 인터루킨(IL)-17 억제제(예: 세쿠키누맙, 익세키주맙, 브로달루맙 또는 비메키주맙) 및 IL-12/23 억제제(예: 우스테키누맙) 또는 IL-23 억제제(예: 구셀쿠맙, 리산키주맙 또는 틸드라키주맙)
  • 만성 신장 감염, 만성 흉부 감염(예: 기관지 확장증), 재발성 요로 감염(재발성 신우신염 또는 만성 비이화성 방광염), 진균 감염(피부점막염)을 포함하되 이에 국한되지 않는 만성 또는 재발성 감염성 질환의 병력이 있는 경우 칸디다증) 또는 개방성, 배수성 또는 감염된 피부 상처 또는 궤양

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: 그룹 1: 구셀쿠맙
참가자는 실명을 유지하기 위해 필요에 따라 위약과 함께 피하 주사로 구셀쿠맙을 투여받게 됩니다.
의약품: 위약
위약은 피하 주사로 투여됩니다.
의약품: 구셀쿠맙
Guselkumab은 피하 주사로 투여됩니다.
다른 이름들:
  • 트렘피아
  • CNTO1959
위약 비교기: 그룹 2: 위약
참가자들은 피하주사로 위약을 투여받고, 피하주사로 구셀쿠맙을 투여받게 된다.
의약품: 위약
위약은 피하 주사로 투여됩니다.
의약품: 구셀쿠맙
Guselkumab은 피하 주사로 투여됩니다.
다른 이름들:
  • 트렘피아
  • CNTO1959

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
기간: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 millimeters (mm); 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Week 16

2차 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
기간: Baseline (Week 0), Week 16
Percent change from baseline in BSA at Week 16 was reported. A BSA was commonly used measure of severity of skin disease. It was defined as the percentage of surface area of the body involved with the condition being assessed, (that is, plaque psoriasis). BSA was assessed using hand print method where the surface area of the participant's hand including the palm and all 5 digits was used as a guide to estimate 1 percent (%) BSA. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percent Change From Baseline in Psoriasis Area Severity Index (PASI) Total Score at Week 16
기간: Baseline (Week 0), Week 16
Percent change from baseline in PASI total score at Week 16 was reported. PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved IGA Score of Cleared (0) at Week 16
기간: Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, greater than (>) 1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Higher score indicated more severe disease.
Week 16
Percentage of Participants Who Achieved PASI 90 Response at Week 16
기간: Week 16
Percentage of participants who achieved PASI 90 score (greater than or equal to [>=] 90% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0 = none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved PASI 100 Response at Week 16
기간: Week 16
Percentage of participants who achieved PASI-100 score (100% improvement from baseline in PASI) at Week 16 was reported. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed and scored separately for erythema, induration, and scaling, which were each rated on a scale of 0 to 4 (0=none, 1 = slight, 2 = moderate, 3 = severe and 4 = very severe) and extent of involvement from 0 (indicated no involvement) to 6 (90% - 100% involvement). The PASI produced a numeric total score that could range from 0 (no psoriasis) to 72 (maximum psoriasis). Higher score indicated greater severity of psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Scalp Specific (ss)-IGA Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Randomized Participants With Ss-IGA Score >=3 at Baseline
기간: Week 16
The ss-IGA instrument was used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness which was scored as: absence of disease = 0, very mild disease = 1, mild disease = 2, moderate disease = 3, and severe disease = 4. A higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Static Physician's Global Assessment of Genitalia (sPGA-G) Score of 0 or 1 at Week 16 Among Randomized Participants With sPGA-G Score >=3 at Baseline
기간: Week 16
The sPGA-G was a 6-point scale to assess the severity of genital psoriasis at a given time point. The sPGA-G evaluates erythema, plaque elevation, and scale of genital psoriatic lesions. The severity of genital psoriasis was assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5). Higher score indicates more severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With an i-IGA Score >=3 at Baseline
기간: Week 16
The IGA used for the full body assessment was adapted with descriptions of disease features that were more consistent with intertriginous psoriasis presentation. The intertriginous areas assessed included the axillary, sub mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The i-IGA was 5-point scale evaluating the severity of plaque psoriasis in the intertriginous area with scores defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated greater disease severity. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Percentage of Participants Who Achieved Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Randomized Participants With f-IGA Score >=3 at Baseline
기간: Week 16
The standard IGA used for full body evaluation was adapted for assessment of psoriasis on the face only. The f-IGA used a 5-point scale to assess overall facial disease severity, defined as clear (0), minimal (1), mild (2), moderate (3), and severe (4). A higher score indicated more severe facial psoriasis. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
기간: Baseline (Week 0), Week 16
The PSSD was a patient reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales were answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Baseline (Week 0), Week 16
Percentage of Participants Who Achieved >=4-Point Improvement From Baseline in PSSD Itch Score at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
기간: Week 16
PSSD was a PRO questionnaire designed to measure severity of psoriasis symptoms and signs for assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms(itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. PSSD itch item score over seven days was averaged into a weekly itch score, ranging from 0 to 10 with higher scores indicating severe disease. Baseline was defined as the closest measurement taken prior to or at time of first study drug administration date.
Week 16
Percentage of Participants Who Achieved PSSD Individual Symptom Scale Score=0 at Week 16 Among Participants With a PSSD Symptom Score >0 at Baseline
기간: Week 16
The PSSD was a PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. 7-day recall version was used. PSSD was a self-administered PRO instrument that included 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Items were averaged on the weekly symptom score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value was converted into 0-100 scoring, such that symptom score = average value*10, where, 0= least severe and 100= most severe. Higher score indicated more severe disease. The baseline was defined as the closest measurement taken prior to or at the time of the first study drug administration date.
Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
기간: Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.
Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
기간: Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56
An AE was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. TEAE was defined as any event that occurred after the start of initial study agent administration and those AEs that were presented at baseline but worsened in severity after the start of initial study agent administration.
Group 1: Placebo: From Week 0 to Week 16; Group 1: Placebo followed by Guselkumab 100 mg: From Week 16 to Week 56; Group 2: Guselkumab 100 mg: From Week 0 to Week 56

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

수사관

  • 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

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)

2023년 8월 24일

기본 완료 (실제)

2025년 4월 14일

연구 완료 (실제)

2025년 4월 14일

연구 등록 날짜

최초 제출

2023년 9월 9일

QC 기준을 충족하는 최초 제출

2023년 9월 9일

처음 게시됨 (실제)

2023년 9월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 10일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CR109328
  • CNTO1959PSO3017 (기타 식별자: Janssen Research & Development, LLC)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Johnson & Johnson의 Janssen 제약회사의 데이터 공유 정책은 www.janssen.com/clinical-trials/transparency에서 확인할 수 있습니다. 이 사이트에 명시된 바와 같이 연구 데이터에 대한 액세스 요청은 Yale Open Data Access(YODA) 프로젝트 사이트 yoda.yale.edu를 통해 제출할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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