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Undersøgelse af Guselkumab versus placebo til behandling af moderat plaquepsoriasis med lav kropsoverfladeareal (SPECTREM)

10. april 2026 opdateret af: Janssen Research & Development, LLC

En fase 3b, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af ​​Guselkumab versus placebo til behandling af lav kropsoverfladeareal (BSA) moderat plakpsoriasis med særlig involvering af stedet

Formålet med denne undersøgelse er at evaluere effektiviteten af ​​guselkumab sammenlignet med et inaktivt lægemiddel hos deltagere med moderat plaque-psoriasis med lav kropsoverflade og involvering af særlige steder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

338

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alle deltagere skal have en diagnose af plaque psoriasis (med eller uden psoriasisgigt) i mindst 6 måneder før første administration af undersøgelsesintervention
  • Alle deltagere skal opfylde følgende kriterier for sygdomssværhedsgrad ved screening og ved baseline: (a) Overordnet Investigator's Global Assessment (IGA) 3 (moderat) plakpsoriasis; (b) Kropsoverfladeareal (BSA) 2-15 procent (%) med mindst 1 plak uden for særlige steder; (c) Involvering af mindst 1 specialsted med mindst moderat sværhedsgrad. Kvalificerende steder inkluderer hovedbund med hovedbundsspecifik IGA større end eller lig med (>=) 3, ansigt med ansigtspsoriasis IGA >=3, intertriginøs med intertriginøs psoriasis IGA >=3 eller genital med statisk læge global vurdering af kønsorganer (sPGA- G) >=3
  • Alle deltagere er utilstrækkeligt kontrolleret med eller intolerante over for mindst 1 tidligere topisk behandling (herunder, men ikke begrænset til, kortikosteroider, retinoider, vitamin D eller vitamin D/steroid og retinoid/steroid kombinationer, tacrolimus, pimecrolimus, anthralin/dithranol, kul tjærepræparater, tapinarof, roflumilast, etcetera) til behandling af psoriasis ved både screening
  • Alle deltagere er kandidater til fototerapi eller systemisk behandling for psoriasis

Ekskluderingskriterier:

  • Har en ikke-plaque form for psoriasis (f.eks. erytrodermisk, guttat eller pustuløs) ved screening eller randomisering
  • Har aktuel lægemiddelinduceret psoriasis (f.eks. en ny debut af psoriasis eller en forværring af psoriasis fra betablokkere, calciumkanalblokkere eller lithium)
  • For deltagere med palmoplantar involvering, bør forvirrende diagnoser, herunder, men ikke begrænset til, palmoplantar pustulose, eksematøs dermatitis, kontakt/irriterende dermatitis, erhvervet keratoderma osv. bekræftes og udelukkes
  • Deltagere vil ikke være berettigede, hvis de nogensinde har modtaget tidligere biologiske (eller biosimilarer af) til behandling af psoriasis, psoriasisgigt (PsA) eller andre indikationer, der kan påvirke vurderingen af ​​psoriasis. Tidligere biologiske lægemidler (eller biosimilarer af) kan omfatte, men ikke begrænset til, tumornekrosefaktor (TNF)-hæmmere (for eksempel: adalimumab, etanercept, infliximab eller certolizumab eller biosimilarer), interleukin (IL)-17-hæmmere (for eksempel: secukinumab, ixekizumab, brodalumab eller bimekizumab) og IL-12/23-hæmmere (for eksempel: ustekinumab) eller IL-23-hæmmere (for eksempel: guselkumab, risankizumab eller tildrakizumab)
  • Har en historie med kronisk eller tilbagevendende infektionssygdom, herunder, men ikke begrænset til, kronisk nyreinfektion, kronisk brystinfektion (f.eks. bronkiektasi), tilbagevendende urinvejsinfektion (tilbagevendende pyelonefritis eller kronisk ikke-remitterende blærebetændelse), svampeinfektion (mukokutan) candidiasis), eller åbne, drænende eller inficerede hudsår eller sår

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Gruppe 1: Guselkumab
Deltagerne vil modtage guselkumab ved subkutan injektion med placebo efter behov for at bevare blindheden.
Medicin: Placebo
Placebo vil blive givet som subkutan injektion.
Medicin: Guselkumab
Guselkumab vil blive administreret som subkutan injektion.
Andre navne:
  • Tremfya
  • CNTO1959
Placebo komparator: Gruppe 2: Placebo
Deltagerne vil modtage placebo ved subkutan injektion og derefter modtage guselkumab ved subkutan injektion.
Medicin: Placebo
Placebo vil blive givet som subkutan injektion.
Medicin: Guselkumab
Guselkumab vil blive administreret som subkutan injektion.
Andre navne:
  • Tremfya
  • CNTO1959

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Research & Development, LLC

Efterforskere

  • Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. august 2023

Primær færdiggørelse (Faktiske)

14. april 2025

Studieafslutning (Faktiske)

14. april 2025

Datoer for studieregistrering

Først indsendt

9. september 2023

Først indsendt, der opfyldte QC-kriterier

9. september 2023

Først opslået (Faktiske)

15. september 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR109328
  • CNTO1959PSO3017 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolitikken for Janssen Pharmaceutical Companies of Johnson & Johnson er tilgængelig på www.janssen.com/clinical-trials/transparency. Som nævnt på dette websted kan anmodninger om adgang til undersøgelsesdataene indsendes gennem Yale Open Data Access (YODA) projektwebsted på yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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