Perennial Allergic Rhinitis (PAR)Phase 2NCT07890350
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
A Phase 2 study testing CM512 in people with Perennial Allergic Rhinitis (PAR), run by Beijing Keymed Biosciences Co., Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinitis (PAR)
- What is being tested?
- CM512
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Mar 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- Pregnancy.
- Other.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality
Qian Jia, 028-88610620, clinicaltrial@keymedbio.com
Luo Zhang
About this study
Official title: 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
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
- Conditions
- Perennial Allergic Rhinitis (PAR)
- Being tested
- CM512, Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM512Biological
Subcutaneous injection, multiple doses. Dosing every 12 weeks (Q12W) or Q24W, according to the protocol. Total treatment duration: 48 weeks.
PlaceboDrug
Subcutaneous injection of matching placebo. multiple doses. Q12W or Q24W according to the protocol. Total treatment duration: 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CM512 | Experimental | Not described Receives: Biological: CM512 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic Rhinitis (PAR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Keymed Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890350
- Sponsor's protocol ID
- CM512-107101
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No