A new medicine being developed for inflammatory bowel disease (IBD) has shown encouraging results in a mid-stage clinical trial, with many participants experiencing long-term symptom control. The drug, called duvakitug, is being developed jointly by Sanofi and Teva Pharmaceuticals for people with ulcerative colitis (UC) and Crohn’s disease, two long-term conditions that cause inflammation in the digestive system. The findings may be relevant to patients who continue to have symptoms despite current treatment options.
Background
Ulcerative colitis and Crohn’s disease are both forms of IBD. They cause ongoing inflammation in the gut, leading to symptoms such as abdominal pain, diarrhoea, and in some cases rectal bleeding. Although several treatments already exist, not everyone responds well to them, and researchers continue to look for medicines that can control symptoms more effectively over the long term.
What the trial found
The trial, known as RELIEVE UCCD, involved 247 people with moderate to severe UC or Crohn’s disease. Participants received one of two doses of duvakitug, given as an injection every four weeks, and were followed for 44 weeks.
Ulcerative colitis
Among people given the higher dose, the researchers reported that nearly six in ten reached remission, meaning symptoms such as rectal bleeding, pain and frequent toilet trips had settled. Almost nine in ten showed a clinical response, meaning their symptoms had meaningfully improved. A similar proportion also showed improvement in the appearance of the gut lining on examination, suggesting reduced inflammation.
Crohn’s disease
People with Crohn’s disease given the higher dose saw comparable results, with the trial authors reporting that around eight in ten reached remission and close to nine in ten showed a clinical response. Examination of the gut also showed meaningful improvement in most of these participants compared with before treatment.
How the drug works
Duvakitug targets a protein called TL1A, which is thought to play a role in gut inflammation and in the scarring that can occur in long-term IBD. By blocking this protein, researchers hope the drug may help calm inflammation and improve symptoms, although more research is needed to confirm how meaningful this effect is over time.
Safety
According to the companies, duvakitug was generally well tolerated during the extended treatment period, with no new safety concerns identified. A small proportion of participants stopped treatment due to side effects, ranging from two to four in every hundred people with UC, and around six in every hundred people with Crohn’s disease.
Why this matters
These results may be welcome news for people living with UC or Crohn’s disease, particularly those who have not had lasting success with existing treatments. If confirmed in further studies, duvakitug could become an additional option for managing these conditions. Sanofi and Teva are already running larger, later-stage trials to test the drug further.
What to keep in mind
This was a mid-stage trial, meaning results still need to be confirmed in larger studies before duvakitug could be considered for approval or routine use. The findings have not yet been published in a peer-reviewed medical journal. People with UC or Crohn’s disease should continue following their current treatment plan and speak to their healthcare team about any questions regarding new research.
Reference
ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease (RELIEVE UCCD). NCT05668013. Available at: https://clinicaltrials.gov/study/NCT05668013
This article is a journalistic summary for informational purposes only. It does not constitute clinical advice or a recommendation to alter treatment decisions.