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Studie av Guselkumab versus placebo for behandling av lav kroppsoverflate moderat plakkpsoriasis (SPECTREM)

10. april 2026 oppdatert av: Janssen Research & Development, LLC

En fase 3b, multisenter, randomisert, dobbeltblind, placebokontrollert studie som evaluerer sikkerheten og effekten av Guselkumab versus placebo for behandling av lav kroppsoverflate (BSA) Moderat plakkpsoriasis med spesiell involvering på stedet

Hensikten med denne studien er å evaluere effekten av guselkumab sammenlignet med et inaktivt medikament hos deltakere med lav kroppsoverflate, moderat plakkpsoriasis og involvering av spesielle steder.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

338

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35244
        • Cahaba Research Inc
      • Birmingham, Alabama, Forente stater, 35203
        • Total Dermatology
    • California
      • Encinitas, California, Forente stater, 92024
        • California Dermatology & Clinical Research Institute
      • Fountain Valley, California, Forente stater, 92708
        • First OC Dermatology
      • Riverside, California, Forente stater, 92505
        • Practice Wang
      • San Diego, California, Forente stater, 92123
        • Therapeutics Clinical Research
      • Santa Ana, California, Forente stater, 92701
        • Rehlen, Bartlow, Goodman and Baron Dermatology Group
      • Santa Monica, California, Forente stater, 90404
        • Clinical Science Institute
    • Connecticut
      • Farmington, Connecticut, Forente stater, 06030
        • University of Conn Health Center
    • Florida
      • Brandon, Florida, Forente stater, 33511
        • TrueBlue Clinical Research
      • Coral Gables, Florida, Forente stater, 33134
        • Florida Academic Dermatology Centers
      • Doral, Florida, Forente stater, 33122
        • Revival Research
      • Margate, Florida, Forente stater, 33063
        • Glick Research Institute
      • Miami, Florida, Forente stater, 33124
        • Miami VA Healthcare System
      • North Miami Beach, Florida, Forente stater, 33162
        • Tory P Sullivan M D PA
    • Georgia
      • Atlanta, Georgia, Forente stater, 303331
        • Atlanta Biomedical Clinical Research
    • Maryland
      • Columbia, Maryland, Forente stater, 21045
        • Kindred Hair and Skin Center
      • Rockville, Maryland, Forente stater, 20850
        • DermAssociates, PC
      • Rockville, Maryland, Forente stater, 20850
        • Lawrence J Green MD LLC
    • Massachusetts
      • Brighton, Massachusetts, Forente stater, 02135
        • Metro Boston Clinical Partners
      • Quincy, Massachusetts, Forente stater, 02169
        • DermCare, LLC
    • Michigan
      • West Bloomfield, Michigan, Forente stater, 48322
        • Henry Ford Medical Center
    • New York
      • New York, New York, Forente stater, 10003
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forente stater, 10128
        • Markowitz Medical OptiSkin
    • North Carolina
      • Cary, North Carolina, Forente stater, 27511
        • Accellacare Research of Cary
      • Charlotte, North Carolina, Forente stater, 28277
        • Darst Dermatology
      • Huntersville, North Carolina, Forente stater, 28078
        • Piedmont Plastic Surgery and Dermatology
    • Ohio
      • Bexley, Ohio, Forente stater, 43209
        • Bexley Dermatology Research
      • Columbus, Ohio, Forente stater, 43215
        • Remington Davis Inc
      • Mayfield Heights, Ohio, Forente stater, 44124
        • Apex Dermatology Mayfield Heights
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29414
        • Dermatology and Laser Center of Charleston
      • Fountain Inn, South Carolina, Forente stater, 29644
        • Palmetto Clinical Trial Services, LLC
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, Forente stater, 37212
        • Nashville Skin: Comprehensive Dermatology Center
    • Texas
      • Arlington, Texas, Forente stater, 76011
        • Arlington Center for Dermatology
      • Bellaire, Texas, Forente stater, 77401
        • Bellair Dermatology
      • Dallas, Texas, Forente stater, 75231
        • Modern Research Associates PLLC
      • Dallas, Texas, Forente stater, 75246
        • Menter Dermatology Research Institute
      • Dallas, Texas, Forente stater, 75235
        • Bare Dermatology
      • Houston, Texas, Forente stater, 77004
        • Center for Clinical Studies
      • Houston, Texas, Forente stater, 77056-4132
        • Suzanne Bruce and Associates - The Center for Skin Research
      • San Antonio, Texas, Forente stater, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, Forente stater, 78218
        • Texas Dermatology and Laser Specialists
      • Sugar Land, Texas, Forente stater, 77479
        • Acclaim Dermatology
    • Washington
      • Mill Creek, Washington, Forente stater, 98102
        • Frontier Derm Partners CRO, LLC

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Alle deltakere må ha en diagnose av plakkpsoriasis (med eller uten psoriasisartritt) i minst 6 måneder før første administrasjon av studieintervensjon
  • Alle deltakere må oppfylle følgende alvorlighetsgradskriterier for sykdom ved screening og ved baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderat) plakkpsoriasis; (b) Body Surface Area (BSA) 2-15 prosent (%) med minst 1 plakett utenfor spesielle steder; (c) Involvering av minst 1 spesialområde med minst moderat alvorlighetsgrad. Kvalifiserte steder inkluderer hodebunn med hodebunnsspesifikk IGA større enn eller lik (>=) 3, ansikt med ansiktspsoriasis IGA >=3, intertriginous med intertriginous psoriasis IGA >=3, eller genital med statisk lege global vurdering av kjønnsorganer (sPGA- G) >=3
  • Alle deltakere er utilstrekkelig kontrollert med eller intolerante overfor minst 1 tidligere topisk behandling (inkludert, men ikke begrenset til, kortikosteroider, retinoider, vitamin D eller vitamin D/steroid og retinoid/steroid kombinasjoner, takrolimus, pimecrolimus, anthralin/ditranol, kull tjærepreparater, tapinarof, roflumilast, etcetera) for behandling av psoriasis ved både screening
  • Alle deltakere er kandidater for fototerapi eller systemisk behandling for psoriasis

Ekskluderingskriterier:

  • Har en ikke-plakk form for psoriasis (eksempel, erytrodermisk, guttat eller pustulær) ved screening eller randomisering
  • Har nåværende medikamentindusert psoriasis (for eksempel en ny debut av psoriasis eller en forverring av psoriasis fra betablokkere, kalsiumkanalblokkere eller litium)
  • For deltakere med palmoplantar involvering, bør forvirrende diagnoser, inkludert, men ikke begrenset, til palmoplantar pustulose, ekzematøs dermatitt, kontakt/irriterende dermatitt, ervervet keratodermi, etcetera, bekreftes og ekskluderes
  • Deltakere vil ikke være kvalifisert hvis de noen gang tidligere har mottatt biologiske (eller biosimilarer av) for behandling av psoriasis, psoriasisartritt (PsA) eller andre indikasjoner som kan påvirke vurderingen av psoriasis. Tidligere biologiske legemidler (eller biosimilarer av) kan inkludere, men ikke begrenset til, tumornekrosefaktor (TNF)-hemmere (for eksempel: adalimumab, etanercept, infliximab eller certolizumab eller biosimilarer), interleukin (IL)-17-hemmere (for eksempel: secukinumab, ixekizumab, brodalumab eller bimekizumab), og IL-12/23-hemmere (for eksempel: ustekinumab), eller IL-23-hemmere (for eksempel: guselkumab, risankizumab eller tildrakizumab)
  • Har en historie med kronisk eller tilbakevendende infeksjonssykdom, inkludert, men ikke begrenset til, kronisk nyreinfeksjon, kronisk brystinfeksjon (for eksempel bronkiektasi), tilbakevendende urinveisinfeksjon (tilbakevendende pyelonefritt eller kronisk ikke-remitterende blærebetennelse), soppinfeksjon (mukokutan) candidiasis), eller åpne, drenerende eller infiserte hudsår eller sår

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gruppe 1: Guselkumab
Deltakerne vil få guselkumab ved subkutan injeksjon med placebo etter behov for å opprettholde blindheten.
Legemiddel: Placebo
Placebo vil bli administrert som subkutan injeksjon.
Legemiddel: Guselkumab
Guselkumab vil bli administrert som subkutan injeksjon.
Andre navn:
  • Tremfya
  • CNTO1959
Placebo komparator: Gruppe 2: Placebo
Deltakerne vil få placebo ved subkutan injeksjon og deretter få guselkumab ved subkutan injeksjon.
Legemiddel: Placebo
Placebo vil bli administrert som subkutan injeksjon.
Legemiddel: Guselkumab
Guselkumab vil bli administrert som subkutan injeksjon.
Andre navn:
  • Tremfya
  • CNTO1959

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. august 2023

Primær fullføring (Faktiske)

14. april 2025

Studiet fullført (Faktiske)

14. april 2025

Datoer for studieregistrering

Først innsendt

9. september 2023

Først innsendt som oppfylte QC-kriteriene

9. september 2023

Først lagt ut (Faktiske)

15. september 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Datadelingspolicyen til Janssen Pharmaceutical Companies of Johnson & Johnson er tilgjengelig på www.janssen.com/clinical-trials/transparency. Som nevnt på dette nettstedet, kan forespørsler om tilgang til studiedata sendes inn via Yale Open Data Access (YODA) prosjektnettsted på yoda.yale.edu

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere