- In UC, duvakitug maintained high rates of clinical remission, clinical response, and endoscopic improvement at Week 44
- In CD, duvakitug maintained high rates of endoscopic response, clinical response, and clinical remission at Week 44
- Duvakitug was well tolerated and safety was consistent with the induction study
PARSIPPANY, N.J. and PARIS, Oct. 20, 2026 (GLOBE NEWSWIRE) —
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safety → maintain → study
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanofi announced new positive data from the RELIEVE UCCD phase 2b long-term extension (LTE) study (clinical trial identifier: NCT05668013) in patients with moderately-to-severely active ulcerative colitis (UC) or Crohn’s disease (CD), which demonstrated that duvakitug maintained clinically meaningful efficacy improvements across multiple endpoints over 44 weeks.
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duvakitug → announce → weeks
Duvakitug is an investigational human monoclonal antibody that targets TL1A, a protein that amplifies inflammation and potentially drives fibrosis in UC and CD.
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that → target → UC
In addition, biomarker findings that advance the understanding of how duvakitug may impact inflammation and tissue remodeling in inflammatory bowel disease (IBD) were shared.
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duvakitug → advance → disease
These data were presented today at United European Gastroenterology (UEG) Week 2026 in Barcelona.
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data → present → Barcelona
The RELIEVE UCCD LTE study evaluated the efficacy, safety, and tolerability of duvakitug through 44 weeks of maintenance treatment after induction in patients with UC and CD, the two most common forms of IBD.
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study → evaluate → IBD
Patients (n=130, 72 with UC and 58 with CD) who responded to duvakitug treatment in the 14-week induction study were randomized to receive either duvakitug 450 mg or 900 mg subcutaneously every four weeks (Q4W) for up to 58 weeks of total exposure.
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who → respond → exposure
At Week 44, maintenance treatment with duvakitug demonstrated high rates of clinical remission and clinical response, as measured by the modified Mayo Score (mMS), meaning active UC symptoms such as rectal bleeding, increased stool frequency, and pain have stopped (remission) or improved (response).
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symptoms → demonstrate → response
Duvakitug treatment also achieved high rates of endoscopic improvement, defined by a Mayo Endoscopic Score of 0 (inactive disease in the colon) or 1 (mild disease activity), which measures the presence and degree of intestinal inflammation.
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which → achieve → inflammation
Efficacy outcomes were numerically higher at 900 mg compared to 450 mg, consistent with a dose response.
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outcomes → compare → response
“Ulcerative colitis can have a significant impact on patients that disrupts even the most basic daily activities.
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that → have → activities
Despite available therapies, some patients continue to experience flares that impact their lives in various ways and may contribute to disease progression,” said Walter Reinisch, MD, PhD, Director of the Inflammatory Bowel Disease Study Group at the Medical University of Vienna and a co-lead investigator of the RELIEVE UCCD LTE study.
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Reinisch → continue → study
“These results underscore the potential of duvakitug to deliver effective and durable relief from persistent inflammation and symptoms, supporting better long-term disease management in patients with ulcerative colitis.”
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results → underscore → colitis
CD Results
Duvakitug maintenance treatment demonstrated high rates of endoscopic response, defined as a 50% or more decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at Week 44.
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treatment → demonstrate → Week
SES-CD assesses mucosal ulcers, the ulcerated surface, the endoscopic extension, and the presence of stenosis in the colon as a gauge of disease severity.
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CD → assess → severity
Additionally, duvakitug maintained high rates of clinical response and clinical remission as measured by the Crohn’s Disease Activity Index (CDAI), meaning symptoms such as abdominal pain, diarrhea, and fatigue have stopped (remission) or improved (response).
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symptoms → maintain → remission
Duvakitug appeared to demonstrate a dose response, with numerically higher efficacy results achieved at the higher dose.
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Duvakitug → appear → dose
“Due to the heterogeneous nature of Crohn’s disease, many patients either stop responding or never respond to available therapies, leaving them with uncontrolled symptoms that cause physical distress,” said Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University and a co-lead investigator of the RELIEVE UCCD LTE study.
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Jairath → stop → study
“The efficacy rates seen with duvakitug in the maintenance period highlight its potential as a new treatment option that could help more patients achieve sustained remission.
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patients → see → remission
Across both UC and CD, duvakitug was generally well tolerated throughout the maintenance period, with a safety profile consistent with the induction phase and no new safety concerns identified.
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concerns → tolerate → phase
The most frequently reported adverse events (AEs) occurring in ≥5% of patients across pooled duvakitug dose groups in UC were upper respiratory tract infection and nasopharyngitis, and in CD were upper respiratory tract infection, CD, hypertension, nasopharyngitis, anemia, and influenza.
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infection → report → CD
Biomarker analyses from the RELIEVE UCCD induction study (clinical trial identifier: NCT05499130) were presented at UEG Week 2026.
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analyses → present → Week
Duvakitug reduced blood levels of markers connected to multiple inflammatory pathways in UC and to the Th17 and Th1 immune pathways in CD, as well as markers of neutrophilic inflammation in both blood and tissue in CD and UC.
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Duvakitug → reduce → CD
In patients with CD, duvakitug also reduced markers of tissue remodeling.
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duvakitug → reduce → remodeling
These findings provide additional mechanistic evidence that TL1A inhibition may address both inflammation and, potentially, fibrosis.
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inhibition → provide → inflammation
Additionally, clinical results from the RELIEVE UCCD induction study were recently published in The Lancet Gastroenterology and Hepatology for UC and CD.
Duvakitug Clinical Development Program
Duvakitug is being investigated in the phase 3 SUNSCAPE-1 (clinical trial identifier: NCT07184996) and SUNSCAPE-2 (clinical trial identifier: NCT07185009) studies in moderately-to-severely active UC, and the phase 3 STARSCAPE-1 (clinical trial identifier: NCT07184931) and STARSCAPE-2 (clinical trial identifier: NCT07184944) studies in moderately-to-severely active CD.
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Duvakitug → publish → CD
Sanofi and Teva have initiated the phase 2 AURALIGHT study (clinical trial identifier: NCT07812116) of duvakitug in moderate-to-severe hidradenitis suppurativa and are planning a phase 2 study of duvakitug in fibrostenotic Crohn’s disease.
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Sanofi → initiate → disease
Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority.
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efficacy → evaluate → authority
About IBD
Inflammatory bowel disease (IBD) is an autoimmune disorder characterized by chronic inflammation of the gastrointestinal (GI) tract.
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disease → characterize → tract
Globally, approximately 4.9 million cases of IBD have been identified, with incidence rising in several regions.
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incidence → identify → regions
The two main types of IBD are ulcerative colitis (UC) and Crohn’s disease (CD), which are characterized by repetitive cycles of relapses and remission.
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which → characterize → relapses
Common symptoms of both conditions include persistent diarrhea, rectal bleeding, abdominal pain, loss of appetite, and weight loss.
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symptoms → include → appetite
Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an excessive accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction.
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which → lead → narrowing
The goal of current treatment is to induce and maintain remission and prevent flares.
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goal → induce → flares
About the RELIEVE UCCD phase 2b program
The RELIEVE UCCD program is comprised of an induction study and a long-term extension (LTE).
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program → comprise → study
The study was an innovative and efficient basket study design allowing the inclusion of patients with either UC or CD.
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study → allow → UC
It is the first and only randomized, blinded and placebo-controlled phase 2 study to investigate the impact of TL1A inhibition in CD.
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It → control → CD
Patients who received duvakitug, completed the 14-week induction study, and were responders, entered a 44-week double-blind maintenance period and were re-randomized to receive either 450 mg or 900 mg of subcutaneous duvakitug every four weeks.
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who → receive → duvakitug
Patients who completed the 44-week maintenance period may continue to receive duvakitug in an open-label extension.
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who → complete → extension
Primary efficacy endpoints for both the 14-week induction study and the 44-week maintenance period are clinical remission (as defined by mMS) in the UC cohort or endoscopic response (as defined by SES-CD) in the CD cohort.
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endpoints → define → cohort
…and 27 more, not listed.