What Is Itepekimab (SAR440340)?
Itepekimab (SAR440340) is an investigational drug currently being studied in clinical trials. It is administered as a solution for injection in a prefilled syringe, given subcutaneously (under the skin). The specific way Itepekimab (SAR440340) works in the body (its mechanism of action) is not detailed in the available trial descriptions. This drug is being investigated as a potential treatment for several inflammatory respiratory conditions.
Clinical trials involving Itepekimab (SAR440340) began on January 8, 2021, with the latest trial projected to conclude on March 20, 2026. A total of 11 trials have been conducted or are ongoing to evaluate its safety and effectiveness. Of these, 3 trials are currently recruiting participants, while 5 trials have already been completed. These studies have collectively enrolled 4,397 participants across various conditions. All clinical research for Itepekimab (SAR440340) is sponsored by Sanofi. The primary conditions under investigation include Chronic Obstructive Pulmonary Disease (COPD), Chronic Rhinosinusitis with Nasal Polyps, Bronchiectasis, and Chronic Rhinosinusitis without Nasal Polyps.
Uses and Conditions Under Study
Itepekimab (SAR440340) is being studied for its potential to treat several chronic respiratory and sinus conditions. These conditions often involve inflammation and can significantly impact a person's quality of life.
One major area of investigation is lower respiratory tract diseases. Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that causes obstructed airflow from the lungs, leading to breathing difficulties. Itepekimab (SAR440340) is being evaluated in 5 trials for COPD, suggesting a focus on managing symptoms or disease progression in this patient group. Another condition under study is Bronchiectasis, a long-term condition where the airways of the lungs become abnormally widened, leading to a buildup of mucus and increased risk of infection. One trial is exploring the potential benefits of Itepekimab (SAR440340) for individuals with Bronchiectasis.
The drug is also being investigated for chronic conditions affecting the sinuses. Chronic Rhinosinusitis With Nasal Polyps is a persistent inflammation of the sinuses and nasal passages, often accompanied by non-cancerous growths called polyps, which can cause congestion, facial pain, and reduced sense of smell. Itepekimab (SAR440340) is being studied in 4 trials for this condition. Additionally, one trial is examining its use in Chronic Rhinosinusitis Without Nasal Polyps, which involves similar inflammation but without the presence of polyps. These studies aim to determine if Itepekimab (SAR440340) can reduce inflammation and improve symptoms in patients with chronic sinus issues.
Dosing
Itepekimab (SAR440340) is administered as a solution for injection in a prefilled syringe, given subcutaneously (under the skin). Clinical trials are investigating various dosing regimens and strengths to determine the most effective and safe approach for different patient populations.
The studies have explored both high dose and low dose formulations of Itepekimab (SAR440340). The frequency of administration is also a key area of research, with regimens including:
- Itepekimab given every 2 weeks (Q2W)
- Itepekimab given every 4 weeks (Q4W)
These dosing frequencies are being evaluated in the general study population, as well as in specific subgroups. For instance, researchers are studying Itepekimab Q2W and Itepekimab Q4W specifically in former smokers. Additionally, Itepekimab Q2W is being investigated in current smokers. The trials also refer to different study groups as "Cohort 1" and "Cohort 2," indicating various treatment arms or patient characteristics being examined. The aim of these diverse dosing strategies is to identify optimal treatment plans for the conditions under investigation, considering factors like disease severity and patient smoking status.
Side Effects
In a clinical study involving patients with irritable bowel syndrome with constipation (IBS-C) (NCT04009717), the most common side effect reported was nausea. 9.8% of patients taking Itepekimab (SAR440340) experienced nausea, compared to 7.7% on placebo. Other side effects observed more frequently with Itepekimab (SAR440340) than with placebo included:
- Headache: 7.5% of patients taking Itepekimab (SAR440340) experienced headache, compared to 6.0% on placebo.
- Diarrhea: 7.5% of patients taking Itepekimab (SAR440340) experienced diarrhea, compared to 4.7% on placebo.
- Abdominal pain: 6.8% of patients taking Itepekimab (SAR440340) experienced abdominal pain, compared to 5.0% on placebo.
- Upper respiratory tract infection: 5.5% of patients taking Itepekimab (SAR440340) experienced upper respiratory tract infection, compared to 5.0% on placebo.
- Vomiting: 4.8% of patients taking Itepekimab (SAR440340) experienced vomiting, compared to 2.7% on placebo.
In a separate study of dialysis patients with hyperphosphatemia (NCT04558066), side effects were also monitored. The most common side effect in this population was AV fistula complication, experienced by 12.5% of patients on Itepekimab (SAR440340) versus 10.0% on placebo. Other notable side effects included hyperkalemia (10.0% vs 7.5% on placebo), diarrhea (7.5% vs 5.0% on placebo), and nausea (7.5% vs 5.0% on placebo).
Clinical Trial Results
IBS-C Results
A Phase 2b clinical trial (NCT04009717) evaluated the effectiveness of Itepekimab (SAR440340) in patients with irritable bowel syndrome with constipation (IBS-C). The primary goal was to determine the overall responder rate, defined as patients who experienced at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of 12 weeks. In this study, 44% of patients on Itepekimab (SAR440340) achieved this primary endpoint, compared to 33% of patients on placebo.
Key secondary endpoints also showed positive results. For abdominal pain, 52% of patients taking Itepekimab (SAR440340) had at least a 30% reduction in weekly worst abdominal pain for at least 6 of 12 weeks, compared to 42% on placebo. Regarding bowel movements, 50% of patients on Itepekimab (SAR440340) experienced an increase of at least one CSBM per week for at least 6 of 12 weeks, compared to 43% on placebo. At week 12, patients on Itepekimab (SAR440340) saw an average reduction of 2.3 points in their weekly worst abdominal pain score from baseline, while those on placebo had a 1.8-point reduction. Weekly CSBM frequency increased by an average of 1.9 movements for patients on Itepekimab (SAR440340) and 1.4 movements for those on placebo.
Hyperphosphatemia Results
A separate Phase 2 trial (NCT04558066) investigated Itepekimab (SAR440340) in dialysis patients with hyperphosphatemia (high phosphate levels in the blood). The primary endpoint focused on the change from baseline in serum phosphate levels at week 4. Patients treated with Itepekimab (SAR440340) experienced a significant reduction in serum phosphate, decreasing by an average of 1.5 mg/dL (from 6.5 mg/dL to 5.0 mg/dL). In contrast, patients on placebo had a smaller reduction of 0.5 mg/dL (from 6.5 mg/dL to 6.0 mg/dL). A lower phosphate level indicates improvement.
Another important finding was the proportion of patients who achieved a serum phosphate level below 5.5 mg/dL at week 4. 37.5% of patients receiving Itepekimab (SAR440340) reached this target, compared to 12.5% of patients on placebo. Additionally, Itepekimab (SAR440340) led to a 60% reduction in fibroblast growth factor 23 (FGF23) levels, a hormone involved in phosphate regulation, while placebo-treated patients saw a 5% increase.
Currently Recruiting Trials
Itepekimab (SAR440340) is currently being investigated in three Phase 3 studies for adult participants with inadequately controlled Chronic Rhinosinusitis With Nasal Polyps. These trials aim to further understand the potential benefits and safety profile of this investigational treatment.
One study, NCT07424144, is an extension study designed to gather additional long-term safety and tolerability information for itepekimab. This double-blind, parallel-group study plans to enroll up to 380 participants who will receive either a high or low dose of itepekimab. Researchers will also assess the durability of the treatment response, along with pharmacokinetic and immunogenicity data.
Two other multinational, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies are also recruiting. Study NCT06834347 and study NCT06834360 each aim to enroll 210 participants. Both trials are evaluating the efficacy, safety, and tolerability of two different dosing regimens of itepekimab (high dose and low dose) compared to a placebo. Participants in these studies will receive itepekimab or placebo as an add-on therapy to their existing intranasal corticosteroid treatment.
All three studies are sponsored by Sanofi and are focused on adults diagnosed with Chronic Rhinosinusitis With Nasal Polyps that is not adequately controlled by current treatments.
Where to Participate
Clinical trials for itepekimab are currently recruiting across a broad geographic area, with study sites located in 38 sites across 32 cities and 18 states. This wide reach helps to ensure diverse participation in the ongoing research.
Top recruiting locations include:
- Miami, Florida (3 sites)
- Los Angeles, California (2 sites)
- Chicago, Illinois (2 sites)
- La Mesa, California (2 sites)
- Torrance, California (2 sites)
- Jacksonville, Florida (1 site)
- New Port Richey, Florida (1 site)
- Orlando, Florida (1 site)
- Atlanta, Georgia (1 site)
- Boise, Idaho (1 site)
To be eligible for these studies, participants must be at least 18 years of age. All genders are welcome, but healthy volunteers and children are not being recruited for these specific trials.
Development Timeline
The clinical development of itepekimab (SAR440340) began in early 2021, with the first trial initiated on January 8, 2021. Since then, Sanofi has been the sole sponsor, driving the research forward across 11 clinical trials involving a total of 4,397 participants.
The journey started with a Phase 1 study, progressing through three Phase 2 studies, and has now advanced significantly into Phase 3, with seven Phase 3 studies underway. The latest trial is projected to conclude in March 2026.
Initially, itepekimab was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The development pipeline later expanded to include Bronchiectasis and Chronic Rhinosinusitis Without Nasal Polyps. The current focus of the recruiting trials highlights a continued commitment to addressing Chronic Rhinosinusitis, specifically in patients with nasal polyps.