Dupilumab Clinical Trials

What Is Dupilumab?

Dupilumab, also known by the brand name Dupixent, is an FDA-approved medication for moderate-to-severe atopic dermatitis (eczema) in adult and pediatric patients aged 6 months and older, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis (EoE). It is a monoclonal antibody that works by blocking the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. These pathways are key drivers of type 2 immune inflammation, which contributes to allergic conditions and inflammation in the skin, airways, and esophagus.

Beyond its approved indications, dupilumab is currently being investigated in 230 clinical trials for a range of other conditions. These studies have enrolled a total of 50,314 participants since the first trial began in 2011. Currently, 54 trials are recruiting new participants, while 105 trials have already been completed, with the latest trial projected to conclude in 2026.

Uses and Conditions Under Study

Dupilumab is being studied for its potential to treat various inflammatory and allergic conditions. The most extensively studied condition is atopic dermatitis, also known as eczema, a skin condition causing rash and itching due to inflammation. Dupilumab helps by targeting the underlying allergic inflammation. There are 80 trials investigating dupilumab for atopic dermatitis, dermatitis atopic, atopic dermatitis (AD), and eczema.

Another significant area of research is asthma. This chronic respiratory condition involves inflammation and narrowing of the airways. Dupilumab is being studied to see if it can help prevent worsening asthma symptoms, especially those triggered by common cold viruses. There are 31 trials focused on asthma.

Dupilumab is also being explored for conditions affecting the sinuses and esophagus. Chronic rhinosinusitis with nasal polyps, a severe form of eosinophilic nasal polyposis, can cause significant symptoms. Dupilumab has shown promise in reducing these clinical manifestations. A total of 19 trials are investigating dupilumab for chronic rhinosinusitis with nasal polyps and nasal polyps. For eosinophilic esophagitis (EoE), a chronic allergic inflammation of the esophagus that can lead to swallowing difficulties and strictures, dupilumab aims to control this allergic inflammation. There are 11 trials for eosinophilic esophagitis (EoE).

Other conditions under investigation include:

• Hypereosinophilic syndrome (HES), which involves elevated eosinophil levels and related symptoms in various organs.
• Localized scleroderma, a group of sclerotic skin disorders.
• Chronic hepatic pruritus (itching related to liver disease).
• Allergic fungal rhinosinusitis (AFRS).
• Its potential role in combination therapies for conditions like estrogen receptor positive (ER+) breast cancer and severe IgE-mediated food allergy.
• Effects on skin barrier function, immune cells in skin lesions, and its use in treating obstructive sleep apnea (OSA).

Dosing

Dupilumab is primarily administered as a subcutaneous (SC) injection. The commercially available form is often provided in 300mg pre-filled syringes. For approved indications, a common adult dosing regimen involves a single loading dose of 600 mg, followed by 300 mg every 2 weeks.

However, various dosing strategies and strengths are being explored in clinical trials. These include different frequencies such as once weekly (qw), every 3 weeks (q3w), or every 4 weeks (q4w). Investigational strengths range from 100 mg, 150 mg, and 200 mg, in addition to the standard 300 mg and 600 mg doses. Some studies are also examining dose reduction or discontinuation strategies to determine the lowest effective dose.

While dupilumab is approved for pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis, specific pediatric dosing regimens are also being studied based on body weight categories. These categories include those weighing 5 kg to <15 kg, 15 kg to <30 kg, 30 kg to <60 kg, and ≥60 kg. Other investigational products, such as IBI3027, IBI356, and GLR1044, are also being studied, typically as subcutaneous injections of 300 mg.

Side Effects

The most common side effect reported in clinical trials for Dupilumab was nasopharyngitis (common cold symptoms). Across 42 trials involving over 9,000 patients, 13.7% of patients taking Dupilumab experienced nasopharyngitis, compared to 10.6% on placebo.

Other common side effects included:

• Injection site reaction: 13.3% of patients on Dupilumab experienced this, compared to 7.5% on placebo.
• Viral upper respiratory tract infection: 12.1% of patients on Dupilumab experienced this, compared to 5.8% on placebo.
• Injection site erythema (redness): 11.1% of patients on Dupilumab experienced this, compared to 2.7% on placebo.
• Upper respiratory tract infection: 9.6% of patients on Dupilumab experienced this, compared to 7.6% on placebo.
• Bronchitis: 9.5% of patients on Dupilumab experienced this, compared to 6.2% on placebo.
• Headache: 7.5% of patients on Dupilumab experienced this, compared to 6.5% on placebo.
• Influenza (flu): 6.0% of patients on Dupilumab experienced this

  Currently Recruiting Trials

  Many clinical trials are currently seeking participants to further understand the effectiveness and safety of dupilumab across a range of conditions. These studies explore new potential uses, compare dupilumab to other treatments, and gather real-world data.
  • A study titled "A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria" (NCT07316114) is enrolling 400 participants in the United States. Sponsored by Sanofi, this non-interventional study aims to describe how dupilumab is used and its effects in patients with chronic spontaneous urticaria in a real-world setting.
  • For patients with moderate-to-severe Atopic Dermatitis, Sanofi is sponsoring a study (NCT07467564) to assess the impact of dupilumab on mental health and quality of life. This non-interventional study is recruiting 184 participants who are already receiving dupilumab treatment.
  • Innovent Biologics (Suzhou) Co. Ltd. is conducting a Phase 2 study (NCT07399067) comparing their investigational drug, IBI3002, against dupilumab in 120 patients with moderate to severe Atopic Dermatitis. This proof-of-concept study evaluates the efficacy and safety of IBI3002.
  • The Mayo Clinic is sponsoring an Early Phase 1 study (NCT07358234) to compare the effects of Eohilia (budesonide oral suspension) with Dupixent (dupilumab) on esophagus diameter and scarring in 60 patients with Eosinophilic Esophagitis.
  • A Phase 3 study (NCT07309614) by Université de Sherbrooke is investigating whether dupilumab can help 150 individuals achieve clinical remission from asthma when administered earlier in the disease course.
  • In Singapore, the National University Hospital is leading a Phase 2 study (NCT07091175) to determine the safety and efficacy of dupilumab in treating severe nephrotic syndrome in 66 children.
  • Sanofi is also sponsoring a Phase 4 study (NCT07053423) involving 218 participants to investigate the effect of dupilumab on airway inflammation in individuals aged 40 to 85 years with Chronic Obstructive Pulmonary Disease.
  • An Early Phase 1 study (NCT06637306) is exploring dupilumab in combination with other therapies for locally advanced Triple Negative Breast Cancer. This trial, sponsored by Rima Patel, aims to assess the safety in 15 participants.
  • The National Institute of Allergy and Infectious Diseases (NIAID) is conducting a Phase 2 study (NCT06477653) for 30 participants with Hypereosinophilic Syndrome who have had a partial response to other biologic agents, evaluating dupilumab as an add-on therapy.
  • Sanofi is sponsoring a Phase 3 study (NCT06191315) called LIBERTY ASTHMA TREKIDS, assessing the efficacy and long-term safety of subcutaneous dupilumab in 90 small children (aged 2 to less than 6 years) with uncontrolled asthma or recurrent severe asthmatic wheeze.

  Where to Participate

  Clinical trials for dupilumab are widely accessible, with research sites spanning across the United States and internationally. There are a total of 361 sites located in 199 cities across 41 states, offering numerous opportunities for participation. Some of the cities with the highest number of recruiting sites include:
  • Chicago, Illinois (11 sites)
  • New York, New York (11 sites)
  • Miami, Florida (11 sites)
  • Boston, Massachusetts (10 sites)
  • San Antonio, Texas (7 sites)
  • Tampa, Florida (6 sites)
  • Philadelphia, Pennsylvania (5 sites)
  • Aurora, Colorado (5 sites)
  • Baltimore, Maryland (5 sites)
  • Charleston, South Carolina (5 sites)
  Eligibility for these trials is broad, welcoming participants aged 1 to 99 years of all genders. Many studies also include children and healthy volunteers, depending on the specific research objectives.

  Development Timeline

  The journey of dupilumab began with its first clinical trial on March 11, 2011, marking the start of extensive research. Since then, a total of 230 trials have been conducted or are ongoing, involving over 50,314 participants. The latest trial is projected to conclude by May 14, 2026, indicating continued investment in understanding this medication. Early investigations initially explored conditions such as IBS-C and hyperphosphatemia. However, the development pipeline quickly expanded, driven primarily by Sanofi and Regeneron Pharmaceuticals, who have sponsored 60 and 47 trials respectively. This collaborative effort led to a significant focus on type 2 inflammatory diseases. Dupilumab's research has progressed through all phases of clinical development, with a substantial number of studies in later stages: 56 Phase 4 (post-marketing), 51 Phase 2, and 50 Phase 3 trials. This progression reflects a comprehensive evaluation of its efficacy and safety. The drug's application has broadened considerably, now encompassing a wide array of conditions including Atopic Dermatitis, Eosinophilic Esophagitis, Chronic Spontaneous Urticaria, Severe Asthma, Chronic Rhinosinusitis With Nasal Polyps, Prurigo Nodularis, and even exploring potential uses in Nephrotic Syndrome in Children and certain cancers like Locally Advanced Triple Negative Breast Cancer. This expansion highlights dupilumab's journey from initial studies to a versatile therapeutic agent for various inflammatory and allergic conditions.