Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy

NCT07890350 — Phase 2, Not yet recruiting, 200 participants, Beijing Keymed Biosciences Co., Ltd.

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A Randomized, Double-Blind, Placebo-Parallel Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy

Registry	NCT07890350
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	200 (Estimated)
Sponsor	Beijing Keymed Biosciences Co., Ltd. (Industry)
Conditions	Perennial Allergic Rhinitis (PAR)
Interventions	CM512, Placebo (Biological, drug)
Dates	start 2026-10-01 (estimated), primary completion 2028-06-01 (estimated), completion 2029-03-01 (estimated), first posted 2026-10-22, last updated 2026-10-22
Locations	1 site in China

-Summary

This is a randomized, double-blind, placebo-parallel controlled phase II study to evaluate the safety and efficacy of CM512 in patients with perennial allergic rhinitis on background therapy

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+Arms and interventions

Arm	Type	Interventions	Description
CM512	Experimental	Biological: CM512
Placebo	Placebo comparator	Drug: Placebo

CM512 (Biological): Subcutaneous injection, multiple doses. Dosing every 12 weeks (Q12W) or Q24W, according to the protocol. Total treatment duration: 48 weeks.
Placebo (Drug): Subcutaneous injection of matching placebo. multiple doses. Q12W or Q24W according to the protocol. Total treatment duration: 48 weeks.

+Outcome measures

Primary outcomes

Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS) at Week 24 [baseline, Week 24]: rTNSS was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. rTNSS is the sum of the rating of all 4 symptoms and ranges from 0-12.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Ability to understand the nature of the study and voluntarily sign the Informed Consent Form (ICF).
* Adult participants ≥18 years and ≤65 years of age at the time of signing the ICF.
* Meet the diagnostic criteria for Allergic Rhinitis (AR), diagnosed with Perennial Allergic Rhinitis (PAR), with a PAR history of at least 1 year, and regularly exposed to perennial allergens in daily life accompanied by related nasal symptoms.
* Positive serum allergen-specific Immunoglobulin E(IgE) test results at screening, confirming that the participant is sensitized to at least one perennial allergen in their current environment, accompanied by consistent clinical symptoms.
* Medical history prior to the screening visit shows that the participant received Intranasal Corticosteroids(INCS) and/or other AR medications within the past 1 year but had inadequate symptom control.
* From the screening visit to randomization, the participant must meet the following symptom score requirements at screening and baseline: rTNSS ≥ 6 and Nasal Congestion score ≥ 2.
* During the screening/run-in period, compliance with diary card recording and adherence to background medication during the run-in period must both be ≥ 80%.
* For participants with comorbid asthma, the investigator or a relevant specialist must confirm that the asthma is stable.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* Pregnancy.
* Other.

+Locations (1)

Facility	City	Country	Status
Beijing Tongren Hospital, CMU	Beijing, Beijing Municipality	China