Evidence map›Paper›PMID 41022848›Full record

Trial reportNature communications2025

An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial.

Mu Xian, Feng Lan, Bing Yan, Shen Shen, Shixi Liu, Lijia Wan, Xicheng Song, Luyun Jiang, Yan Jiang, Jinmei Xue and 24 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05324137 (A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05324137 phase1 / phase2completednot on this map

A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

TypeinterventionalSponsorKeymed Biosciences Co.LtdRan2022 to 2024Enrolled88ConditionsChronic Rhinosinusitis With Nasal PolypsArmsCM326, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Mu Xian *Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
Feng Lan *Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0000-0002-1709-5179
Bing Yan *Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.ORCID http://orcid.org/0000-0003-2206-3750
Shen Shen *Department of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China.
Shixi LiuDepartment of Otorhinolaryngology, Head and Neck Surgery, West China Hospital Sichuan University, Chengdu, Sichuan, China.
Lijia WanDepartment of Otorhinolaryngology, Head and Neck Surgery, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, Hubei, China.
Xicheng SongDepartment of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, China.
Luyun JiangDepartment of Otorhinolaryngology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Yan JiangDepartment of Otorhinolaryngology, Head and Neck Surgery, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
Jinmei XueDepartment of Otorhinolaryngology, Head and Neck Surgery, the Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Jianjun ChenDepartment of Otorhinolaryngology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Lizhong SuDepartment of Otolaryngology, People's Hospital of Hangzhou Medical College, Hangzhou, Zhejiang, China.
Jing YeDepartment of Otorhinolaryngology, Head and Neck Surgery, the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.
Yucheng YangDepartment of Otorhinolaryngology, the First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Hongyan FangDepartment of Otorhinolaryngology, Head and Neck Surgery, Chongqing General Hospital, Chongqing, China.
Guolin TanDepartment of Otorhinolaryngology, Head and Neck Surgery, the Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
Qinna ZhangDepartment of Otorhinolaryngology, Head and Neck Surgery, the First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
Shenhong QuDepartment of Otolaryngology, Head and Neck Surgery, The People's Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China.
Xin WeiDepartment of Otorhinolaryngology Head and Neck Surgery, Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University, Haikou, Hainan, China.
Xianyang LuoDepartment of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Yu XuDepartment of Rhinology and Allergy, Renmin Hospital of Wuhan University, Wuhan, Hubei, China.
Shaoqing YuDepartment of Otolaryngology Head and Neck Surgery, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China.ORCID http://orcid.org/0000-0003-2208-4535
Zian XiaoDepartment of Otorhinolaryngology, Head and Neck Surgery, the Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
Feng LiuDepartment of Otorhinolaryngology, Head and Neck Surgery, West China Hospital Sichuan University, Chengdu, Sichuan, China.
Qin LiDepartment of Otorhinolaryngology, Head and Neck Surgery, Jingzhou Hospital Affiliated to Yangtze University, Jingzhou, Hubei, China.
Yu ZhangDepartment of Otorhinolaryngology, Head and Neck Surgery, Yantai Yuhuangding Hospital, Qingdao University, Yantai, Shandong, China.
Yan XieDepartment of Otorhinolaryngology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Lin WangDepartment of Otorhinolaryngology, Head and Neck Surgery, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.
Guoping YangCentre for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.ORCID http://orcid.org/0000-0001-5930-586X
Hongyue YanKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Guoqing ZhaoKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Bo ChenKeymed Biosciences (Chengdu) Co., Ltd, Chengdu, Sichuan, China.
Chengshuo WangDepartment of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. wangcs830@126.com.ORCID http://orcid.org/0000-0003-0646-5135
Luo ZhangDepartment of Otolaryngology, Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. dr.luozhang@139.com.ORCID http://orcid.org/0000-0002-0910-9884

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To explore the therapeutic potential of blocking thymic stromal lymphopoietin (TSLP) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), we conducted a phase 1b/2a, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of CM326, a monoclonal antibody against TSLP. We enrolled 84 eligible patients with uncontrolled CRSwNP and stratified them based on baseline tissue eosinophil count. Patients are assigned to receive CM326 220 mg (n = 40) or placebo (n = 20) every 2 weeks (Q2W) and CM326 220 mg (n = 20) or placebo (n = 4) every 4 weeks (Q4W) for 16 weeks. Subsequently, all patients continue on CM326 220 mg Q2W or Q4W for an additional 36 weeks, followed by a 12-week follow up. Primary endpoints are safety of CM326 and change from baseline in NPS at week 16 in patients with eosinophilic CRSwNP (ECRSwNP). Main secondary endpoints include the change from baseline in NPS at week 16 in non-eosinophilic CRSwNP (nonECRwNP) and pharmacodynamic markers. Throughout the 64-week study, all treatment-emergent adverse events (TEAEs) are mild or moderate. CM326 Q2W improves NPS in patients with ECRSwNP compared with placebo at week 16 (mean difference [95% CI], -1.2 [-2.3 to -0.1], P = 0.04), with sustained benefits during the open-label and follow-up periods. Notably, peripheral blood and tissue eosinophil counts and concentrations of plasma IL-13 and IL-5 are reduced by week 16 with the treatment of CM326 Q2W versus placebo. A post-hoc analysis demonstrates that all participants with baseline TSLP > 330 fg/mL achieve a substantial reduction in NPS by week 16 with the treatment of CM326 Q2W (mean difference vs. placebo: -1.75 [95%CI, -3.06 to -0.44], P = 0.01). Overall, CM326 is well tolerated and effective in patients with uncontrolled ECRSwNP. A baseline plasma TSLP level of 330 fg/mL may serve as a predictive marker for treatment efficacy of CM326. ClinicalTrials.gov Identifier: NCT05324137.

Indexed as

Antibodies, MonoclonalCytokinesNasal PolypsRhinitisSinusitisAdultAgedChronic DiseaseDouble-Blind MethodEosinophilsFemaleHumansInterleukin-13Interleukin-5MaleMiddle AgedAntibodies, MonoclonalCytokinesInterleukin-13Interleukin-5Thymic Stromal LymphopoietinTSLP protein, human

Identifiers

PMID41022848
PMCPMC12480939

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.