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Studio di Guselkumab rispetto al placebo per il trattamento della psoriasi a placche moderata con superficie corporea ridotta (SPECTREM)

10 aprile 2026 aggiornato da: Janssen Research & Development, LLC

Uno studio di fase 3b, multicentrico, randomizzato, in doppio cieco, controllato con placebo che valuta la sicurezza e l'efficacia di guselkumab rispetto al placebo per il trattamento della psoriasi a placche moderata con area di superficie corporea ridotta (BSA) con coinvolgimento di siti speciali

Lo scopo di questo studio è valutare l'efficacia di guselkumab rispetto a un farmaco inattivo nei partecipanti con psoriasi a placche moderata a bassa superficie corporea e coinvolgimento di siti speciali.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

338

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Tutti i partecipanti devono avere una diagnosi di psoriasi a placche (con o senza artrite psoriasica) da almeno 6 mesi prima della prima somministrazione dell'intervento in studio
  • Tutti i partecipanti devono soddisfare i seguenti criteri di gravità della malattia allo screening e al basale: (a) Psoriasi a placche (moderata) secondo la valutazione globale dello sperimentatore (IGA) 3; (b) Area della superficie corporea (BSA) 2-15% (%) con almeno 1 placca al di fuori di siti speciali; (c) Coinvolgimento di almeno 1 sito speciale con gravità almeno moderata. I siti qualificanti includono cuoio capelluto con IGA specifico per il cuoio capelluto maggiore o uguale a (>=) 3, viso con IGA di psoriasi facciale >= 3, intertriginoso con IGA di psoriasi intertriginosa >= 3 o genitale con valutazione globale statica dei genitali da parte del medico (sPGA- G) >=3
  • Tutti i partecipanti non sono adeguatamente controllati o sono intolleranti ad almeno 1 precedente terapia topica (inclusi, ma non limitati a, corticosteroidi, retinoidi, vitamina D o combinazioni vitamina D/steroidi e retinoidi/steroidi, tacrolimus, pimecrolimus, antralina/ditranolo, carbone preparati di catrame, tapinarof, roflumilast, eccetera) per il trattamento della psoriasi sia allo screening
  • Tutti i partecipanti devono essere candidati alla fototerapia o al trattamento sistemico per la psoriasi

Criteri di esclusione:

  • Presenta una forma di psoriasi senza placche (ad esempio, eritrodermica, guttata o pustolosa) allo screening o alla randomizzazione
  • Ha una psoriasi indotta da farmaci (ad esempio, una nuova insorgenza di psoriasi o un'esacerbazione della psoriasi da beta-bloccanti, bloccanti dei canali del calcio o litio)
  • Per i partecipanti con coinvolgimento palmoplantare, diagnosi confondenti, incluse, ma non limitate, a pustolosi palmoplantare, dermatite eczematosa, dermatite da contatto/irritante, cheratoderma acquisito, eccetera, devono essere confermate ed escluse
  • I partecipanti non saranno idonei se hanno mai ricevuto in precedenza farmaci biologici (o biosimilari) per il trattamento della psoriasi, dell'artrite psoriasica (AP) o qualsiasi altra indicazione che potrebbe influire sulla valutazione della psoriasi. I precedenti prodotti biologici (o biosimilari di) possono includere, ma non limitati a, inibitori del fattore di necrosi tumorale (TNF) (ad esempio: adalimumab, etanercept, infliximab o certolizumab o biosimilari), inibitori dell'interleuchina (IL)-17 (ad esempio: secukinumab, ixekizumab, brodalumab o bimekizumab) e inibitori di IL-12/23 (ad esempio: ustekinumab) o inibitore di IL-23 (ad esempio: guselkumab, risankizumab o tildrakizumab)
  • Ha una storia di malattie infettive croniche o ricorrenti, incluse, ma non limitate a, infezione renale cronica, infezione cronica del torace (ad esempio bronchiectasie), infezione ricorrente del tratto urinario (pielonefrite ricorrente o cistite cronica non remittente), infezione fungina (mucocutanea candidosi), o ferite o ulcere cutanee aperte, drenanti o infette

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Gruppo 1: Guselkumab
I partecipanti riceveranno guselkumab mediante iniezione sottocutanea con placebo secondo necessità per mantenere la cecità.
Droga: Placebo
Il placebo sarà somministrato come iniezione sottocutanea.
Droga: Guselkumab
Guselkumab verrà somministrato come iniezione sottocutanea.
Altri nomi:
  • Tremfya
  • CNTO1959
Comparatore placebo: Gruppo 2: placebo
I partecipanti riceveranno il placebo mediante iniezione sottocutanea, quindi riceveranno guselkumab mediante iniezione sottocutanea.
Droga: Placebo
Il placebo sarà somministrato come iniezione sottocutanea.
Droga: Guselkumab
Guselkumab verrà somministrato come iniezione sottocutanea.
Altri nomi:
  • Tremfya
  • CNTO1959

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Body Surface Area (BSA) at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Investigatori

  • Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 agosto 2023

Completamento primario (Effettivo)

14 aprile 2025

Completamento dello studio (Effettivo)

14 aprile 2025

Date di iscrizione allo studio

Primo inviato

9 settembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2023

Primo Inserito (Effettivo)

15 settembre 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR109328
  • CNTO1959PSO3017 (Altro identificatore: Janssen Research & Development, LLC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

La politica di condivisione dei dati delle società farmaceutiche Janssen di Johnson & Johnson è disponibile all'indirizzo www.janssen.com/clinical-trials/transparency. Come indicato su questo sito, le richieste di accesso ai dati dello studio possono essere inviate tramite il sito del progetto Yale Open Data Access (YODA) all'indirizzo yoda.yale.edu

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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