The effect of baricitinib in the treatment of chronic rhinosinusitis with refractory polyps.

Evaluation of the Efficacy of Baricitinib in the Treatment of Patients with Chronic Rhinosinusitis with Treatment-Resistant Nasal Polyps

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20181230042174N3

Enrollment

Registered

2025-03-17

Start date

2025-04-09

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pansinusitis and Nasal polyp. Nasal polyp, unspecified

Interventions

Intervention 1: Intervention group: Baricitinib Group: Baseline treatment (saline irrigation and nasal corticosteroids) + baricitinib for 6 months to assess efficacy and safety. Intervention 2: Contro

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Disease: Patients with chronic rhinosinusitis with treatment-resistant nasal polyps. Age Range: 18 to 60 years. Inflammation Evidence: Evidence of TH2 inflammation. Diagnosis Confirmation:Confirmation of chronic rhinosinusitis with treatment-resistant nasal polyps based on clinical and imaging criteria.Having undergone at least one prior nasal polyp surgery.Current uncontrolled disease (active condition). Referral Location: Patients referred to Hazrat-e Rasool Akram Hospital Tehran (under the supervision of Iran University of Medical Sciences) during the years 2025

Exclusion criteria

Exclusion criteria: Unwillingness: Lack of willingness to participate in the study. Specific Medication Use:Use of systemic corticosteroids or systemic antibiotics outside the study protocol. Specific Clinical Conditions:Pregnancy.Active viral diseases (e.g., hepatitis, chickenpox).Active or latent tuberculosis.Concomitant autoimmune disease or malignancy. Non-compliance: Patient’s inability or unwillingness to cooperate with follow-up.

Design outcomes

Primary

Measure	Time frame
Nasal polyp size. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination of polyps by an ENT specialist and CT scan findings.;Symptoms related to rhinosinusitis and asthma. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.;Need for elimination or reduction of systemic corticosteroids and antibiotics. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.;Quality of life. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using the completion of the SNOT-22 questionnaire by the patient.;Adverse effects of baricitinib include warts, molluscum, tuberculosis, hematologic complications, and drug intolerance. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.	—

Measure

Time frame

Nasal polyp size. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination of polyps by an ENT specialist and CT scan findings.;Symptoms related to rhinosinusitis and asthma. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.;Need for elimination or reduction of systemic corticosteroids and antibiotics. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.;Quality of life. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using the completion of the SNOT-22 questionnaire by the patient.;Adverse effects of baricitinib include warts, molluscum, tuberculosis, hematologic complications, and drug intolerance. Timepoint: At the start of treatment (month 0), and months 2, 4, and 6 thereafter. Method of measurement: Using clinical examination by an ENT and asthma/allergy specialist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayeh Heidary Ghadikolaeii

Iran University of Medical Sciences

Heidary.so@iums.ac.ir+98 21 6435 2528

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026