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A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease (DUET ENCORE-CD)

5. Mai 2026 aktualisiert von: Janssen Research & Development, LLC

A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive [worsens with time] and life-threatening disease of the intestine).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

460

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion criteria:

  • Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
  • Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >= 2.0, based on the unweighted CDAI component of abdominal pain (AP)
  • Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
  • Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies

Exclusion criteria:

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC
  • Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study
  • Presence of draining (that is, functioning) stoma or ostomy
  • Has a history of short bowel syndrome, is missing greater than (>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention
  • Currently has or is suspected of having an abscess

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: JNJ-78934804
Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.
Arzneimittel: JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Andere Namen:
  • JNJ-4804
Aktiver Komparator: Guselkumab
Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
Arzneimittel: Guselkumab
Guselkumab wird subkutan verabreicht.
Andere Namen:
  • TREMFJA
Arzneimittel: JNJ-78934804
JNJ-78934804 will be administered subcutaneously.
Andere Namen:
  • JNJ-4804

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Co-Primary: Percentage of Participants with Clinical Remission at Week 48
Zeitfenster: At Week 48
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 48
Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48
Zeitfenster: At Week 48
Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 48

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants with Deep Remission at Week 48
Zeitfenster: At Week 48
Deep remission (composite endpoint) is defined as achieving both clinical remission and endoscopic remission at Week 48 at the participant level. Clinical remission is defined as a CDAI score of <150 and Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore >1 in any individual component. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 48
Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48
Zeitfenster: At Week 48
Corticosteroid-free (90-day) clinical remission at Week 48 is defined as clinical remission at Week 48 and not receiving corticosteroids for at least 90 days prior to Week 48. Clinical remission is defined as a CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 48
Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48
Zeitfenster: At Week 48
Corticosteroid-free (90-day) patient-reported outcome(s) (PRO-2) remission at Week 48 is defined as an abdominal plan (AP) mean daily score less than or equal to (<=) 1 and stool frequency (SF) mean daily score <= 2.8, and no worsening of AP or SF from baseline, and not receiving corticosteroids for at least 90 days prior to Week 48.
At Week 48
Percentage of Participants with Sustained Clinical Remission
Zeitfenster: At Weeks 12 and 48
Sustained clinical remission is defined as clinical remission at Week 12 and Week 48. Clinical remission is defined as CDAI score of <150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Weeks 12 and 48
Percentage of Participants with Histologic-Endoscopic Remission at Week 48
Zeitfenster: At Week 48
Histologic-endoscopic remission at week 48 is defined as achieving a combination of histologic remission and endoscopic remission at Week 48. Histologic remission is defined as absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, or ulcerations or granulation tissue as assessed by the Robarts Histopathology Index. Endoscopic remission is defined as a SES-CD score of <= 4 with at least a 2-point reduction from baseline and no subscore > 1 in any individual component.
At Week 48
Percentage of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Response at Week 48
Zeitfenster: At Week 48
IBDQ response at Week 48 is defined as an improvement of at least 16 points in the IBDQ total score from baseline at Week 48. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate disease-specific health related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, AP), systemic function (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.
At Week 48
Percentage of Participants with Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) Mental Component Summary Score (MCS) Response at Week 48
Zeitfenster: At Week 48
PROMIS-29 MCS response at Week 48 is defined as an improvement of at least 7 points in PROMIS-29 MCS score from baseline at Week 48. The PROMIS-29 is a collection of short forms containing 4 items for each of 7 domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities). PROMIS-29 also includes an overall average pain intensity 0-10 numeric rating scale. The PROMIS-29 MCS will be assessed, which is primarily informed by domains of emotional distress (depression/anxiety) and fatigue as well as sleep disturbance where higher MCS scores reflect better mental health.
At Week 48
Percentage of Participants with Clinical Remission at Week 12
Zeitfenster: At Week 12
Clinical remission at Week 12 is defined as CDAI score <150 at Week 12. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 12
Percentage of Participants with Endoscopic Response at Week 12
Zeitfenster: At Week 12
Endoscopic response at Week 12 is defined as greater than (>) 50 percent (%) improvement from baseline in SES-CD score at Week 12 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 12
Number of Participants with Adverse Events (AE) and Serious AEs (SAEs)
Zeitfenster: Up to approximately 3 years
An AE is 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. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product, and is medically important.
Up to approximately 3 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Research & Development, LLC

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

29. Mai 2026

Primärer Abschluss (Geschätzt)

12. Juni 2028

Studienabschluss (Geschätzt)

12. Juli 2030

Studienanmeldedaten

Zuerst eingereicht

5. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 78934804CRD3001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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