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低体表面積中等度尋常性乾癬の治療におけるグセルクマブとプラセボの研究 (SPECTREM)

2026年4月10日 更新者：Janssen Research & Development, LLC

特別な施設の関与を伴う低体表面積（BSA）中等度尋常性乾癬の治療におけるグセルクマブとプラセボの安全性と有効性を評価する第 3b 相、多施設共同、無作為化、二重盲検、プラセボ対照試験

この研究の目的は、体表面積が小さく、中等度の尋常性乾癬および特殊な部位の病変を有する参加者において、不活性薬剤と比較してグセルクマブの有効性を評価することである。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

338

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • すべての参加者は、治験介入の最初の投与前に少なくとも6か月間、尋常性乾癬（乾癬性関節炎の有無にかかわらず）の診断を受けていなければなりません
  • すべての参加者は、スクリーニング時およびベースライン時に以下の重症度基準を満たさなければなりません：（a）総合調査員による総合評価（IGA）3（中等度）尋常性乾癬。 (b) 体表面積 (BSA) が 2 ～ 15 パーセント (%) で、特別な部位の外側に少なくとも 1 つのプラークがある。 (c) 少なくとも中等度の重大度を伴う少なくとも 1 つの特殊な部位の関与。 適格な部位には、頭皮特異的 IGA が (>=) 3 以上の頭皮、顔面乾癬 IGA >=3 の顔、間部乾癬 IGA >=3 の膣間部、または静的医師による生殖器全体評価 (sPGA-) のある生殖器が含まれます。 G) >=3
  • すべての参加者は、少なくとも1つの以前の局所療法（コルチコステロイド、レチノイド、ビタミンD、またはビタミンD/ステロイドおよびレチノイド/ステロイドの組み合わせ、タクロリムス、ピメクロリムス、アントラリン/ジトラノール、石炭を含むがこれらに限定されない）によるコントロールが不十分であるか、それらに耐えられない両方のスクリーニングで乾癬の治療のためのタール製剤、タピナロフ、ロフルミラストなど）
  • すべての参加者は乾癬の光線療法または全身治療の候補者である

除外基準:

  • スクリーニングまたはランダム化時に非プラーク型の乾癬（例、紅皮症、滴状、または膿疱性）を患っている
  • 現在薬剤性乾癬を患っている（たとえば、ベータ遮断薬、カルシウムチャネル遮断薬、またはリチウムによる乾癬の新たな発症または乾癬の悪化）
  • 掌蹠に病変がある参加者については、掌蹠膿疱症、湿疹性皮膚炎、接触性/刺激性皮膚炎、後天性角皮症などを含むがこれらに限定されない、複雑な診断を確認し、除外する必要があります。
  • 乾癬、乾癬性関節炎（PsA）、または乾癬の評価に影響を与える可能性のあるその他の適応症の治療のため、以前に生物学的製剤（またはそのバイオシミラー）を投与されたことのある参加者は参加資格がありません。 従来の生物製剤（またはそのバイオシミラー）には、腫瘍壊死因子（TNF）阻害剤（例：アダリムマブ、エタネルセプト、インフリキシマブ、セルトリズマブまたはバイオシミラー）、インターロイキン（IL）-17阻害剤（例：セクキヌマブ、イセキズマブ、ブロダルマブ、またはビメキズマブ）、および IL-12/23 阻害剤（例: ウステキヌマブ）、または IL-23 阻害剤（例: グセルクマブ、リサンキズマブ、またはチルドラキズマブ）
  • 慢性腎感染症、慢性胸部感染症（気管支拡張症など）、再発性尿路感染症（再発性腎盂腎炎または慢性非寛解性膀胱炎）、真菌感染症（皮膚粘膜感染症など）を含むがこれらに限定されない、慢性または再発性の感染症の病歴がある。カンジダ症）、または開いた、滲出性の、または感染した皮膚の創傷または潰瘍

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：グループ 1: グセルクマブ
参加者は、失明を維持するために必要に応じて、プラセボとともにグセルクマブを皮下注射されます。
薬：プラセボ
プラセボは皮下注射として投与されます。
薬：グセルクマブ
グセルクマブは皮下注射として投与されます。
他の名前：
  • トレムフィア
  • CNTO1959
プラセボコンパレーター：グループ 2: プラセボ
参加者は皮下注射によりプラセボを投与され、次に皮下注射によりグセルクマブを投与されます。
薬：プラセボ
プラセボは皮下注射として投与されます。
薬：グセルクマブ
グセルクマブは皮下注射として投与されます。
他の名前：
  • トレムフィア
  • CNTO1959

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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

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スポンサー

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年8月24日

一次修了 (実際)

2025年4月14日

研究の完了 (実際)

2025年4月14日

試験登録日

最初に提出

2023年9月9日

QC基準を満たした最初の提出物

2023年9月9日

最初の投稿 (実際)

2023年9月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月1日

QC基準を満たした最後の更新が送信されました

2026年4月10日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CR109328
  • CNTO1959PSO3017 (その他の識別子：Janssen Research & Development, LLC)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

ジョンソン・エンド・ジョンソンのヤンセンファーマ会社のデータ共有ポリシーは、www.janssen.com/clinical-trials/transparency でご覧いただけます。 このサイトに記載されているように、研究データへのアクセス要求は、Yale Open Data Access (YODA) プロジェクト サイト (yoda.yale.edu) から送信できます。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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