Living with Crohn's disease can be challenging, and finding effective treatments is crucial for improving quality of life. This study evaluates guselkumab, a new treatment, to see how well it works and how safe it is for people with moderately to severely active Crohn's disease. The research includes three separate studies over 48 weeks, focusing on different aspects of treatment effectiveness. The first study will measure changes in disease activity after 12 weeks, while the other two will look at both clinical response and remission rates after 12 and 48 weeks. With 1,409 participants involved, this research aims to provide valuable insights into how guselkumab can help manage symptoms and potentially lead to longer-term improvements. If proven effective, this treatment could be a game-changer for many individuals battling this condition.
Guselkumab Shows Promise in Crohn's Disease: Phase 3 Study ResultsCan a new treatment help people with Crohn's disease feel better and stay better?
AI-generated summary of the cited source, checked by automated accuracy review. How we work
Key Takeaway
Evaluate guselkumab's efficacy in Crohn's disease through ongoing Phase 2/3 trials.
This ongoing Phase 2/3 study investigates the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease. The study includes three separate trials: GALAXI 1, a 48-week Phase 2 dose-ranging study, and GALAXI 2 and GALAXI 3, both 48-week Phase 3 confirmatory studies. The primary outcomes focus on changes in the Crohn's Disease Activity Index (CDAI) score at Week 12 for GALAXI 1, and the percentage of participants achieving both clinical response at Week 12 and clinical remission at Week 48 for GALAXI 2. Additionally, GALAXI 2 evaluates the percentage of participants achieving both clinical response at Week 12 and endoscopic response at Week 48. A total of 1409 participants have been enrolled, with the study's primary completion date noted as October 20, 2023. The study is sponsored by Janssen Research & Development, LLC, and results are expected to be posted by May 7, 2025. Participants completing the 48-week studies may enter a long-term extension phase. The study assesses efficacy, pharmacokinetics, biomarkers, and safety, aiming to identify optimal induction and maintenance dosing regimens.
What this means for you:
Guselkumab may offer new hope for managing Crohn's disease symptoms effectively. More on Crohn's Disease
Acute cellular senescence facilitates tissue repair while chronic accumulation drives intestinal fibrosis in Crohn's disease
Chronic cell aging may drive scarring in Crohn's disease
This systematic review examines the role of cellular senescence in intestinal fibrosis within Crohn's disease. The authors conclude that acu…
New research reveals how the timing of cellular aging determines whether your body heals properly or develops harmful scar tissue.
Mucus-barrier regulatory programs in Crohn's disease and ulcerative colitis involve ER stress and microbial sensing
New findings show how mucus barriers fail in Crohn's and Ulcerative Colitis
This meta-analysis of transcriptomic datasets and an Agr2-/- mouse model identifies consensus mucus-barrier regulatory programs in active IB…
Researchers found that specific genes control the protective mucus layer in the gut. These same pathways are disrupted in people with IBD.
IBD-related neuroimaging shows brain alterations in emotional networks with distinguishable phenotypes for Crohn's and ulcerative colitis
Brain scans show different emotional patterns in Crohn's and ulcerative colitis
This bibliometric analysis and systematic scoping review examines 175 articles on IBD-related neuroimaging literature from Web of Science an…
A review of 175 articles found that brain activity in Crohn's and ulcerative colitis affects emotion centers differently. This suggests dist…
Darvadstrocel shows 48.8% combined remission in Crohn's perianal fistulas, not superior to placebo
Darvadstrocel showed no better results than placebo for Crohn's disease fistulas
This Phase 3 randomized trial in adults with Crohn's disease and complex perianal fistulas found that darvadstrocel did not achieve a statis…
A major trial found darvadstrocel did not improve closure of Crohn's fistulas compared to placebo, showing no significant benefit for patien…
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2/PHASE3
Condition(s): Crohn's Disease
Intervention(s): Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG), Guselkumab Dose 4 (DRUG), Guselkumab Dose 5 (DRUG)
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
Detailed: This program consists of 3 separate studies: a 48-week Phase 2 dose-ranging study (GALAXI 1) and two 48-week Phase 3 confirmatory studies (GALAXI 2 and GALAXI 3). In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Participants who complete the 48-week Phase 2 or Phase 3 studies may be eligible to enter the long term extension (LTE). Throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.
Primary Outcome(s): GALAXI 1: Change From Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12; Global: GALAXI 2: Percentage of Participants With Both Clinical Response at Week 12 and Clinical Remission at Week 48; Global: GALAXI 2: Percentage of Participants With Both Clinical Response (CR) at Week 12 and Endoscopic Response (ER) at Week 48
Enrollment: 1409 (ACTUAL)
Lead Sponsor: Janssen Research & Development, LLC
Start: 2018-04-13 | Primary Completion: 2023-10-20
Results posted: 2025-05-07
Higher TyG Index Linked to 4.36-Fold Increased Odds of NAFLD in Large Meta-Analysis
TyG Index Linked to Higher Fatty Liver Risk
Related in Gastroenterology
Acupuncture modulates the microbiota-gut-brain axis to remodel microbial structure in patients with irritable bowel syndrome
Acupuncture May Help Manage Irritable Bowel Syndrome Symptoms
This systematic review examines how acupuncture influences the microbiota-gut-brain axis in patients with irritable bowel syndrome. The auth…
New research suggests acupuncture may help manage irritable bowel syndrome by improving gut bacteria and balancing the gut-brain connection.
Reduced Shannon index indicates lower alpha-diversity in the gut microbiota of patients with primary biliary cholangitis
Gut Microbiota Differences Linked to Primary Biliary Cholangitis
This meta-analysis of 1,057 participants found that patients with primary biliary cholangitis have significantly lower Shannon index values …
A large review of patient data shows that people with primary biliary cholangitis have significantly lower gut bacterial diversity than heal…
Probiotic supplementation may improve salivary buffering and reduce cariogenic bacteria
A review of six studies shows probiotics may help oral and gut health in people
This systematic review of 6 reviews suggests probiotic supplementation may improve salivary buffering capacity and plaque pH, reduce Strepto…
This review looked at six studies on probiotic supplements. Results suggest better saliva function and fewer bad mouth bacteria, though stud…
Balloon-assisted ESD shows comparable outcomes to conventional ESD for colorectal polyps
Balloon-assisted endoscopic submucosal dissection shows shorter procedure time in RCTs
This systematic review and meta-analysis of 1449 patients found that balloon-assisted endoscopic submucosal dissection (BA-ESD) and conventi…
A meta-analysis of 1,449 patients found balloon-assisted endoscopic submucosal dissection had shorter procedure times in randomized trials, …
From Other Specialties
Meningeal Immune System Offers New Target for Glioblastoma Immunotherapy
New approach targets the immune system to treat brain tumors
This systematic review explores how targeting the meningeal immune system, including dural lymphatics and rBAMs, could overcome current barr…
A new strategy focuses on the area where brain tumors meet the body's defenses to improve how immunotherapy works for glioblastoma.
A 6 dimension and 42 item system provides early risk assessment for high-risk diabetic feet
Experts Develop New Risk Assessment System for Diabetic Feet
This expert consultation and guideline describes the development of an early risk assessment system for high-risk diabetic feet. The consens…
A new assessment system identifies risk factors like nerve damage and circulation to help manage and prevent complications in patients with …
Rapid advancements in imaging and blood-based biomarkers are transforming the diagnosis and management of ADRD
New guidelines help doctors tell delirium from dementia
This clinical guideline provides a narrative review on the evolving diagnostic and treatment landscape for Alzheimer's disease and related d…
Delirium is acute and fluctuating; dementia is chronic. New guidelines help doctors tell them apart.
ACTH and vigabatrin achieved full seizure control in a patient with Ververi-Brady syndrome
ACTH and Vigabatrin Show Promise for Rare Epilepsy Syndrome
This case report describes a 5-month-old male infant with Ververi-Brady syndrome and infantile epileptic spasms syndrome. The patient achiev…
A new gene variant linked to Ververi-Brady syndrome showed positive results when treated with a combination of ACTH and vigabatrin.