A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: lunsekimig; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06454240

2024-511261-11 (Registry Identifier)

ACT18207

U1111-1300-6978 (Other Identifier)

Details and patient eligibility

About

This is a parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP.

The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups.

The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A minimum bilateral nasal polyp score of 5 out of a maximum score of 8 for both nostrils (with at least a score of 2 for each nostril) despite use of intranasal corticosteroid treatment for at least 2 months prior to screening

Ongoing symptoms for at least 2 months prior to screening, including:

• Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
• At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

• Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
• Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
• Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
• Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
• Active/chronic helminthic infection
• History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
• Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Participant will receive placebo subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Treatment:

Drug: placebo

Arm 2

Experimental group

Description:

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) for 24 weeks.

Treatment:

Drug: lunsekimig