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Not yet recruitingNCT07890350Updated Oct 22, 2026

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

A Phase 2 interventional study of CM512 and Placebo in Perennial Allergic Rhinitis (PAR), sponsored by Beijing Keymed Biosciences Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Beijing Keymed Biosciences Co., Ltd. (part of Keymed Biosciences Co.Ltd) · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Perennial Allergic Rhinitis (PAR)
03

In context

Rhinitis, Allergic, Perennial

186 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 8 are open to participants now.

This study's planned enrollment of 200 is above the median of 131 across 164 interventional studies indexed under Rhinitis, Allergic, Perennial.

Browse Rhinitis, Allergic, Perennial studies →

Lead sponsor

Beijing Keymed Biosciences Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Browse Beijing Keymed Biosciences Co., Ltd. studies →All Keymed Biosciences Co.Ltd studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    CM512

    Biological: CM512

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • BiologicalCM512

    Subcutaneous injection, multiple doses. Dosing every 12 weeks (Q12W) or Q24W, according to the protocol. Total treatment duration: 48 weeks.

  • DrugPlacebo

    Subcutaneous injection of matching placebo. multiple doses. Q12W or Q24W according to the protocol. Total treatment duration: 48 weeks.

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS) at 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.

    Time frame: baseline, Week 24

07

Study locations

1 site
  • Beijing Tongren Hospital, CMU
    Beijing, Beijing Municipality, China
    • Qian Jia · Contact · clinicaltrial@keymedbio.com · 028-88610620
    • Luo Zhang · Principal investigator
    • Chengshuo Wang · Principal investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartEst.
Oct 2026
Primary completionEst.
Jun 2028
CompletionEst.
Mar 2029
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07890350
Lead sponsor
Beijing Keymed Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Oct 22, 2026

Study contacts

Qian Jia
Contact
clinicaltrial@keymedbio.com
028-88610620

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: CM512

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