Trial reportGut2006
A dose escalating, placebo controlled, double blind, single dose and multidose, safety and tolerability study of fontolizumab, a humanised anti-interferon gamma antibody, in patients with moderate to severe Crohn's disease.
Trial report in Gut, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
57 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Biologic therapy for Crohn's disease (2015-2025): a bibliometric analysis of global research trends and current status.Frontiers in pharmacology · 2026Pooled it
- Systematic review: outcomes and adverse events from randomised trials in Crohn's disease.Alimentary pharmacology & therapeutics · 2019Pooled it
- IFN-γ drives inflammatory bowel disease pathogenesis through VE-cadherin-directed vascular barrier disruption.The Journal of clinical investigation · 2019Trial
- Immunopathogenesis and Therapeutics of Systemic Lupus Erythematosus: an Integrative Review.Clinical reviews in allergy & immunology · 2025Review
- Mucosal Responses to Type II Interferon in IBD.Inflammatory bowel diseases · 2025Article
- Targeting Interferon-Gamma (IFN-γ)-Related Signalling Pathways in Inflammatory Bowel Disease: Emerging Inhibitors and Therapeutic Advances.Mediators of inflammation · 2025Review
- Single-Cell and Spatial Multi-omics Reveal Interferon Signaling in the Pathogenesis of Perianal Fistulizing Crohn's Disease.bioRxiv : the preprint server for biology · 2024Article
- Recent advances in bacteria-based platforms for inflammatory bowel diseases treatment.Exploration (Beijing, China) · 2024Review
- Novel 5-HTAmerican journal of physiology. Gastrointestinal and liver physiology · 2024Article
- Crosstalk Between Microbiota, Microbial Metabolites, and Interferons in the Inflammatory Bowel Disease Gut.Journal of the Canadian Association of Gastroenterology · 2024Review
- Spermidine Ameliorates Colitis via Induction of Anti-Inflammatory Macrophages and Prevention of Intestinal Dysbiosis.Journal of Crohn's & colitis · 2023Article
- Divergent roles for STAT4 in shaping differentiation of cytotoxic ILC1 and NK cells during gut inflammation.Proceedings of the National Academy of Sciences of the United States of America · 2023Article
- Biofilm's Impact on Inflammatory Bowel Diseases.Cureus · 2023Review
- Evaluation of oxidative stress in an experimental model of Crohn's disease treated with hyperbaric oxygen therapy.Clinics (Sao Paulo, Brazil) · 2023Article
- Targeting IL-6 by engineered Lactococcus lactis via surface-displayed affibody.Microbial cell factories · 2022Article
- IFN-γCellular & molecular immunology · 2022Article
- Human autoantibodies underlying infectious diseases.The Journal of experimental medicine · 2022Article
- Oral delivery of a functional algal-expressed TGF-β mimic halts colitis in a murine DSS model.Journal of biotechnology · 2021Article
- Targeting interferon-γ in hyperinflammation: opportunities and challenges.Nature reviews. Rheumatology · 2021Review
- Sustained Post-Developmental T-Bet Expression Is Critical for the Maintenance of Type One Innate Lymphoid CellsFrontiers in immunology · 2021Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study was designed to evaluate the safety of fontolizumab, a humanised anti-interferon gamma antibody, in patients with moderate to severe Crohn's disease (CD). PATIENTS AND
methodsForty five patients with a CD activity index (CDAI) of 250-450 were randomised in a double blind, placebo controlled, dose escalating fashion to receive single doses of fontolizumab (0.1, 1.0, and 4.0 mg/kg) or placebo. By day 29, patients with clinical response were re-randomised to receive three additional doses of one half their initial fontolizumab dose or placebo at four weekly intervals. Primary objectives were safety and tolerability. Secondary outcomes included assessments of immunogenicity, clinical activity, and potential pharmacodynamic surrogates.
resultsTreatment was generally well tolerated. There were slightly more reports of chills, flu-like syndrome, asthenia, nausea, and vomiting in the 1.0 mg and 4.0 mg/kg fontolizumab cohorts. Two serious adverse events rated as worsening of CD occurred under fontolizumab. Antibodies to fontolizumab were confirmed in one patient. No differences in clinical activity parameters were noted between any of the active treatment groups and placebo, with the placebo group having a particularly favourable outcome (60% response and 40% remission). By day 29, a more enhanced decrease in median Crohn's disease endoscopic index of severity (p = 0.02) and serum C reactive protein (p<0.001) was observed in the 4.0 mg/kg (n = 14) fontolizumab cohort compared with placebo (n = 10). Pharmacodynamic effects were observed by immunohistochemistry.
conclusionsFontolizumab was well tolerated with minimal immunogenicity at doses of up to 4.0 mg/kg in patients with CD. A biological activity of fontolizumab is suggested.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.