Pumecitinib nasal spray for moderate-to-severe SAR: Phase 2 trial

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Created On: 09/10/2026

Seasonal allergic rhinitis (SAR) triggers widespread mucosal inflammation driven by underlying immune pathways, notably involving Janus kinase (JAK) signaling.

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Key take away

Intranasal administration of pumecitinib at 1.2 mg and 2.0 mg twice daily successfully mitigates both nasal and ocular symptom burdens while maintaining a favorable safety profile in adults with moderate-to-severe seasonal allergic rhinitis.

Background

Seasonal allergic rhinitis (SAR) triggers widespread mucosal inflammation driven by underlying immune pathways, notably involving Janus kinase (JAK) signaling. Although systemic therapies exist, targeted topical intranasal options require robust clinical data to establish their therapeutic viability. Researchers set out to measure the clinical efficacy, safety profile, and pharmacokinetic behavior of multiple dosage strengths of pumecitinib nasal spray delivered over a two-week period during peak pollen season.

Method

Study conductors organized a randomized controlled phase 2 study across 20 distinct medical facilities. A cohort of 168 adult volunteers aged 18 through 65 years experiencing moderate-to-severe SAR was divided evenly in a 1:1:1:1 allocation to receive either a matching placebo solution or pumecitinib nasal spray at concentrations of 0.2 mg, 1.2 mg, or 2.0 mg applied twice daily across 14 consecutive days. Primary analysis tracked alterations from baseline in daily reflective total nasal symptom scores, whereas secondary parameters evaluated ocular manifestations and validated quality-of-life questionnaires.

Result

All 168 randomized subjects completed the 14-day therapeutic protocol across the four study arms, revealing distinct clinical responses and safety outcomes detailed below:

Primary symptom reduction: Participants treated with the 1.2 mg and 2.0 mg formulations achieved notable reductions in daily reflective total nasal symptom score (rTNSS) changes when compared to the control cohort, as shown in Table 1:

Secondary ocular and quality-of-life gains: Both effective dosage tiers yielded substantial enhancements regarding reflective total ocular symptom scores, isolated nasal-ocular manifestations, and overall rhinoconjunctivitis quality-of-life questionnaire (RQLQ) over placebo.
Adverse event distribution: Documented treatment-emergent adverse event frequencies reached 24% within the placebo arm, 15% in the low-dose 0.2 mg group, 33% in the 1.2 mg cohort, and 21% in the high-dose 2.0 mg group.
Tolerability and severity patterns: Nearly all recorded untoward medical events remained mild in intensity, showing no discernible correlation with escalating dosage amounts or systemic toxicity concerns.

Conclusion

Twice-daily application of pumecitinib nasal spray at 1.2 mg or 2.0 mg effectively eased pollen-induced nasal and ocular distress without causing dose-related safety complications, thereby laying a solid groundwork for upcoming expansive clinical evaluations.

Source:

The Lancet Regional Health - Western Pacific

Link:

https://www.thelancet.com/journals/lanwpc/article/PIIS2666-6065(26)00173-2/fulltext

Article:

Efficacy, safety, and pharmacokinetics of pumecitinib nasal spray for moderate-to-severe seasonal allergic rhinitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial