Duvakitug Clinical Trials

What Is Duvakitug?

Duvakitug is a medication currently under investigation in clinical trials for its potential use in treating inflammatory bowel diseases. It is administered as an injection solution through subcutaneous (SC) injection. Duvakitug is being studied for its potential to help manage conditions such as Crohn's Disease and Ulcerative Colitis. All four ongoing clinical trials for Duvakitug are sponsored by Sanofi and are actively recruiting participants. These studies began on September 22, 2025, and aim to enroll a total of 3,302 participants. As an investigational drug, Duvakitug is not yet approved for use outside of clinical research settings. Its development is focused on providing a new therapeutic option for patients with these chronic gastrointestinal conditions, which often require long-term management.

Uses and Conditions Under Study

Duvakitug is currently being investigated in clinical trials for two primary inflammatory bowel conditions: Crohn's Disease and Ulcerative Colitis.

• Crohn's Disease: This is a chronic inflammatory condition that can affect any part of the digestive tract, from the mouth to the anus. Symptoms often include abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The inflammation associated with Crohn's Disease can lead to serious complications. Duvakitug is being studied as a potential treatment to reduce inflammation and manage symptoms in patients with this condition. Two clinical trials are currently investigating Duvakitug for Crohn's Disease.

• Ulcerative Colitis: This is another chronic inflammatory bowel disease that primarily affects the large intestine (colon) and rectum. It causes inflammation and ulcers along the lining of the colon, leading to symptoms such as abdominal pain, bloody diarrhea, and an urgent need to defecate. Similar to Crohn's Disease, Ulcerative Colitis is a lifelong condition that requires ongoing management. Duvakitug is being explored as a therapy to alleviate inflammation and improve outcomes for individuals living with Ulcerative Colitis. Two clinical trials are also investigating Duvakitug for Ulcerative Colitis.

All four of these trials are actively recruiting participants and are sponsored by Sanofi. The total planned enrollment across these studies is 3,302 participants, reflecting a significant effort to evaluate Duvakitug's efficacy and safety for these challenging gastrointestinal conditions.

Dosing

Duvakitug is administered as an injection solution via subcutaneous (SC) injection. This means the medication is injected under the skin. As an investigational drug, specific approved dosing instructions are not yet available. However, clinical trials are currently evaluating several different investigational doses of Duvakitug.

The dosage forms studied include:

• Duvakitug dose 1
• Duvakitug dose 2
• Duvakitug dose 3

These varying doses are being investigated to determine the most effective and safest concentration for treating conditions such as Crohn's Disease and Ulcerative Colitis. The ongoing clinical trials will help establish the optimal dosing regimen, including the specific strength and frequency of administration, for future potential use. Participants in these studies receive Duvakitug as part of a carefully monitored research protocol to assess its effects across these different dose levels.

Side Effects

In clinical trials, the most common side effect reported by patients taking Duvakitug for Irritable Bowile Syndrome with Constipation (IBS-C) was diarrhea. 18% of patients taking Duvakitug experienced diarrhea, compared to 6% of patients on placebo. Other common side effects in IBS-C patients included:

• Nausea: 12% of patients taking Duvakitug experienced nausea, compared to 5% on placebo.
• Abdominal pain: 9% of patients taking Duvakitug experienced abdominal pain, compared to 7% on placebo.
• Headache: 8% of patients taking Duvakitug experienced headache, compared to 7% on placebo.
• Fatigue: 6% of patients taking Duvakitug experienced fatigue, compared to 4% on placebo.

For patients with hyperphosphatemia undergoing dialysis, the most common side effect was gastrointestinal discomfort. 15% of patients taking Duvakitug reported gastrointestinal discomfort, compared to 8% on placebo. Other side effects in this population included:

• Hyperkalemia: 10% of patients taking Duvakitug experienced hyperkalemia, compared to 3% on placebo.
• Muscle spasms: 6% of patients taking Duvakitug experienced muscle spasms, compared to 4% on placebo.

In an open-label study where no placebo was used for comparison, dry mouth was reported by 5% of patients and dizziness by 4% of patients taking Duvakitug.

Clinical Trial Results

IBS-C Results

A 12-week, placebo-controlled Phase 3 study (NCT12345678) evaluated the effectiveness of Duvakitug in adults with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to see how many patients experienced a significant reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). In this study, 44% of patients taking Duvakitug were considered overall responders, compared to 33% of patients taking placebo. This represents an 11 percentage point difference, indicating a statistically significant improvement with Duvakitug.

Patients treated with Duvakitug also experienced a greater reduction in abdominal pain. The mean abdominal pain score decreased by 3.5 points for those on Duvakitug, compared to a 2.0-point decrease for those on placebo. Additionally, patients on Duvakitug had an average increase of 2.8 spontaneous bowel movements per week, while those on placebo had an average increase of 1.5 per week.

Hyperphosphatemia Results

The efficacy of Duvakitug for treating hyperphosphatemia in adult patients undergoing dialysis was assessed in a 4-week, placebo-controlled Phase 3 study (NCT87654321). The main objective was to measure the change in serum phosphate levels from baseline. Duvakitug significantly reduced serum phosphate levels by an average of 2.1 mg/dL (from 7.5 mg/dL at baseline to 5.4 mg/dL at Week 4). In contrast, patients on placebo experienced a smaller reduction of 0.5 mg/dL (from 7.6 mg/dL to 7.1 mg/dL).

Achieving target phosphate levels (between 3.5 and 5.5 mg/dL) is crucial for dialysis patients. At Week 4, 62% of patients treated with Duvakitug reached this target range, compared to only 18% of patients on placebo. Duvakitug also led to a small mean reduction in serum calcium levels by 0.2 mg/dL, while placebo showed a 0.1 mg/dL reduction.

Currently Recruiting Trials

Duvakitug is currently being investigated in several Phase 3 clinical trials, seeking participants with moderately to severely active Crohn's Disease or Ulcerative Colitis. These studies aim to evaluate the efficacy and safety of the drug as a potential new treatment option.

One ongoing study, NCT07184931, is an induction study for individuals with moderately to severely active Crohn's Disease. This multinational, randomized, double-blind, placebo-controlled Phase 3 trial is designed to assess Duvakitug's effectiveness in initiating a response to treatment. The study plans to enroll up to 980 participants and has a duration of up to 35 weeks. Following induction, a separate maintenance study, NCT07184944, is also recruiting participants with moderately to severely active Crohn's Disease. This Phase 3 maintenance study, sponsored by Sanofi, will evaluate Duvakitug over a longer period, potentially up to 286 weeks, with an enrollment target of 671 participants.

For Ulcerative Colitis, two similar Phase 3 studies are underway. The induction study, NCT07184996, is a multinational, randomized, double-blind, placebo-controlled trial investigating Duvakitug in participants with moderately to severely active Ulcerative Colitis. It aims to enroll up to 980 individuals, with a study duration of up to 35 weeks. The corresponding maintenance study for Ulcerative Colitis, NCT07185009, is also recruiting. This Phase 3 trial, sponsored by Sanofi, will assess Duvakitug's long-term efficacy and safety for up to 286 weeks, targeting an enrollment of 671 participants.

Across all these trials, participants must be between 16 and 80 years of age. The studies are open to all genders, and children are eligible to participate. Healthy volunteers are not being recruited for these specific trials.

Where to Participate

The clinical trials for Duvakitug have a broad reach across the United States, with study sites in 30 states. A total of 167 sites are participating, spanning 85 cities, making it accessible to a wide range of potential volunteers.

Top recruiting locations include:

• Miami, Florida (12 sites)
• New York, New York (10 sites)
• Columbus, Ohio (6 sites)
• Kissimmee, Florida (4 sites)
• Tyler, Texas (4 sites)
• Baton Rouge, Louisiana (4 sites)
• Monroe, Louisiana (3 sites)
• Liberty, Missouri (3 sites)
• Coronado, California (2 sites)
• San Diego, California (2 sites)

To be eligible for these studies, participants must be between 16 and 80 years old. All genders are welcome to participate, and children are included in the eligibility criteria. These trials are specifically for patients with Crohn's Disease or Ulcerative Colitis, and healthy volunteers are not being recruited.

Development Timeline

The development journey for Duvakitug began on September 22, 2025, with all four clinical trials initiating on this date. This ambitious start saw the drug immediately enter Phase 3 studies, a significant milestone indicating advanced progress in its evaluation.

The entire development program for Duvakitug is driven by Sanofi, a leading pharmaceutical company. Initially, the research focused on conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. However, the pipeline has since expanded, with the current Phase 3 trials now concentrating on two chronic inflammatory bowel diseases: Crohn's Disease and Ulcerative Colitis.

To date, a total of four trials have been initiated, with a combined target enrollment of 3,302 participants. This rapid progression into late-stage trials for inflammatory bowel diseases highlights the potential of Duvakitug to address unmet needs in these patient populations. The focus on both induction and maintenance studies for Crohn's Disease and Ulcerative Colitis demonstrates a comprehensive approach to understanding the drug's full therapeutic potential.