A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease



Sponsor:   AbbVie


Sommario: Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any
part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal
pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in
participants treated for moderately to severely active CD. Adverse events and change in
the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the
induction period, there is a 1 in 5 chance that participants will be assigned to placebo.
Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3
chance that participants will be assigned to placebo in the maintenance period. Around
265 participants 18-75 years of age with moderately to severely active CD will be
enrolled in the study at approximately 200 sites worldwide.

The study is comprised of a 12-week double-blind, placebo-controlled induction period,
followed by either a 12-week double-blind re-induction period for non-responders or a
40-week double-blind placebo-controlled maintenance period for responders. In the
maintenance period, responders will be randomized to receive subcutaneous placebo or
ABBV-154 in 2 different doses every other week. Participants in the placebo group who are
initial responders will receive ABBV-154 in the maintenance period.

There may be higher treatment burden for participants in this trial compared to their
standard of care due to study procedures. 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 2




TRATTAMENTO

  
    
  
  • ABBV-154
  • Placebo
  • ABBV-154
  • Placebo
    • 






OBIETTIVO PRIMARIO


  
  • Misura: Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Tempo: Baseline to Week 12
  • Descrizione: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal
inflammation. Endoscopic response is defined as a decrease in 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). The SES-CD evaluates 4 endoscopic variables (ulcer
size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none)
to 3 (worst) in 5 segments assessed during ileocolonoscopy (ileum, right colon,
transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the
4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more
severe disease.




OBIETTIVO SECONDARIO


  
  • Misura: Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)
  • Tempo: Induction Period Week 12
  • Descrizione: The CDAI consists of 8 components; 6 are based on participant diary entries, participant
interviews, and physical examinations, and 2 are based on laboratory analysis, and
measurement of body weight and height. Clinical remission is defined as CDAI < 150.
  • Misura: Percentage of Participants Achieving Clinical Remission Per Average Daily Liquid or Very Soft Stool Frequency (SF) and Average Daily Abdominal Pain (AP) Score (SF/AP)
  • Tempo: Induction Period Week 12
  • Descrizione: Clinical remission is defined as average daily liquid or very soft stool SF <= 2.8 and
not worse than Baseline and average daily AP score <= 1 and not worse than Baseline.
  • Misura: Percentage of Participants Achieving Endoscopic Response Per SES-CD
  • Tempo: Week 40 in the Maintenance Period
  • Descrizione: The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal
inflammation. Endoscopic response is defined as a decrease in 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 Clinical Remission Per CDAI
  • Tempo: Week 40 in the Maintenance Period
  • Descrizione: The CDAI consists of 8 components; 6 are based on participant diary entries, participant
interviews, and physical examinations, and 2 are based on laboratory analysis, and
measurement of body weight and height. Clinical remission is defined as CDAI < 150.
  • Misura: Percentage of Participants Achieving Clinical Remission Per SF/AP
  • Tempo: Week 40 in the Maintenance Period
  • Descrizione: Clinical remission is defined as average daily liquid or very soft SF <= 2.8 and not
worse than Baseline and average daily AP score <= 1 and not worse than Baseline.




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
     of the Induction Period.

  -  Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction
     Period.

  -  Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic
     Score for Crohn's Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or
     SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All
     eligible scores must exclude the presence of narrowing component.

  -  Demonstrated intolerance or inadequate response to one or more of the following
     biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab,
     natalizumab, ustekinumab, or risankizumab.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 18 Years

Età Massima: 75 Years






LUOGO


  
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
Rho	3169447, 20017
Policlinico Agostino Gemelli /ID# 233380
Rome	3169070, 00168
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
Bari	3182351, 70124
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
Milan	3173435, 20122