Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)



Sponsor:   AbbVie


Sommario: 
      Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any
      part of the gut. This study will evaluate how well risankizumab works compared to
      ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).

      Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease
      (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD.
      Participants are randomly assigned to one of the three treatment groups. Each group receives
      a different treatment. There is a 1 in 2 chance that participants will be assigned to
      ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in
      approximately 307 sites worldwide.

      In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of
      risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week
      48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at
      Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2,
      participants who received risankizumab in Part 1 and completed the Week 48 visit will
      continue to receive SC risankizumab for up to an additional 220 weeks.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of the treatment will be checked by medical assessments, blood tests,
      checking for side effects and completing questionnaires.
    




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 3




TRATTAMENTO

  
    
  
  • Risankizumab
  • Risankizumab
  • Ustekinumab
  • Ustekinumab
    • 






OBIETTIVO PRIMARIO


  
  • Misura: Percentage of Participants Achieving Clinical Remission at Week 24
  • Tempo: Week 24
  • Descrizione: Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
  • Misura: Percentage of Participants Achieving Endoscopic Remission
  • Tempo: Week 48
  • Descrizione: Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
  • Misura: Number of Participants Reporting Adverse Events
  • Tempo: Up to 220 Weeks
  • Descrizione: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.




OBIETTIVO SECONDARIO


  
  • Misura: Percentage of Participants Achieving Clinical Remission at Week 48
  • Tempo: Week 48
  • Descrizione: Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
  • Misura: Percentage of Participants Achieving Endoscopic Response at Week 48
  • Tempo: Week 48
  • Descrizione: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  • Misura: Percentage of Participants Achieving Endoscopic Response at Week 24
  • Tempo: Week 24
  • Descrizione: Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  • Misura: Percentage of Participants Achieving Steroid-Free Endoscopic Remission
  • Tempo: Week 48
  • Descrizione: Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
  • Misura: Percentage of Participants Achieving Steroid-Free Clinical Remission
  • Tempo: Week 48
  • Descrizione: Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    
        Inclusion Criteria:

          -  Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.

          -  Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.

          -  Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool
             frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD
             (SES-CD).

          -  Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis
             factor (TNF) therapies.

        Exclusion Criteria:

          -  Current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or
             any investigational biologic or other agent or procedure prior to Baseline (as
             detailed in protocol).

          -  Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).

          -  Currently know complications of CD (strictures, short bowel, etc).
      
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: 80 Years






LUOGO


  
Azienda Ospedaliera San Camillo Forlanini /ID# 223325
Rome, 00152
Policlinico Agostino Gemelli /ID# 223323
Rome, 00168
Ospedale San Raffaele IRCCS /ID# 241167
Milan, 20132
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
Rho, 20017
Fondazione PTV Policlinico Tor Vergata /ID# 223332
Rome, 00133
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
Negrar, 37024
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330
Bologna, 40138
Azienda Ospedaliera G. Brotzu /ID# 241165
Cagliari, 09121
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474
Cagliari, 09124
Ospedale Policlinico San Martino /ID# 223329
Genova, 16132
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322
Milano, 20157
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324
Milan, 20122
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333
Palermo, 90146