ChiCTR2600120206 版本V1.0 版本创建时间2026/03/10 17:47:43 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600120206 

最近更新日期：

Date of Last Refreshed on：

 2026-03-10 17:47:03 

注册时间：

Date of Registration：

 2026-03-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评估HB0043(IL-17A/IL-36R双抗)在成人中度至重度痤疮受试者中有效性和安全性的临床试验

Public title：

A clinical trial to evaluate the efficacy and safety of HB0043(IL-17A/IL-36R bispecific antibody) in adult subjects with moderate to severe acne

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评估HB0043(IL-17A/IL-36R双抗)在成人中度至重度痤疮受试者中有效性和安全性的临床试验

Scientific title：

A clinical trial to evaluate the efficacy and safety of HB0043(IL-17A/IL-36R bispecific antibody) in adult subjects with moderate to severe acne

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张福仁 

研究负责人：

张福仁 

Applicant：

Furen Zhang 

Study leader：

Furen Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 531 87298847

研究负责人电话：

Study leader's
telephone：

+86 531 87298808

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 suohandong@126.com

研究负责人电子邮件：

Study leader's E-mail：

 zhangfuren@hotmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

山东省济南市槐荫区经十路27397号

研究负责人通讯地址：

山东省济南市槐荫区经十路27397号

Applicant address：

No. 27397, Jingshi Road, Huaiyin District, Jinan City, Shandong

Study leader's address：

No. 27397, Jingshi Road, Huaiyin District, Jinan City, Shandong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

山东第一医科大学附属皮肤病医院

Applicant's institution：

Shandong Provincial Institute of Dermatology and Venereology

研究负责人所在单位：

山东第一医科大学附属皮肤病医院

Affiliation of the Leader：

Shandong Provincial Institute of Dermatology and Venereology

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 20260302IIT002

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

山东第一医科大学附属皮肤病医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Hospital for Skin Diseases, Shandong First Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-02 00:00:00

伦理委员会联系人：

赵伟

Contact Name of the ethic committee：

Zhao Wei

伦理委员会联系地址：

山东省济南市槐荫区经十路27397号

Contact Address of the ethic committee：

No. 27397, Jingshi Road, Huaiyin District, Jinan City, Shandong Province, China.

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 87298817

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 sdpysll@163.com

研究实施负责（组长）单位：

山东第一医科大学附属皮肤病医院

Primary sponsor：

Shandong Provincial Institute of Dermatology and Venereology

研究实施负责（组长）单位地址：

山东省济南市槐荫区经十路27397号

Primary sponsor's address：

No. 27397, Jingshi Road, Huaiyin District, Jinan City, Shandong Province, China.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

Country：

China

Province：

Shandong

City：

单位(医院)：

山东第一医科大学附属皮肤病医院

具体地址：

山东省济南市槐荫区经十路27397号

Institution
hospital：

Shandong Provincial Institute of Dermatology and Venereology

Address：

No. 27397, Jingshi Road, Huaiyin District, Jinan City, Shandong Province, China.

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Independent Research Project (Self-Funded)

研究疾病：

痤疮  

Target disease：

Acne

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评估HB0043在面部中度至重度寻常痤疮受试者中的有效性。 评估HB0043在面部中度至重度寻常痤疮受试者中的安全性和耐受性。 评估HB0043在面部中度至重度寻常痤疮受试者中的药效学（PD）指标情况。  

Objectives of Study：

To evaluate the efficacy of HB0043 in subjects with moderate to severe facial acne vulgaris. To evaluate the safety and tolerability of HB0043 in subjects with moderate to severe facial acne vulgaris. To evaluate the pharmacodynamic (PD) indicators of HB0043 in subjects with moderate to severe facial acne vulgaris.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.理解本研究程序且自愿书面签署知情同意书（ICF）。 2.签署ICF时年龄≥18周岁的男性或女性。 3.受试者患有中度至重度面部寻常痤疮，并满足以下标准： a.病灶累及至少包括面部，可累及身体其他部位； b.满足中重度痤疮标准：炎性结节数量≥5，伴有囊肿或窦道； c.IGA评分4分； 4.在研究期间，受试者必须避免使用其他治疗痤疮的方法； 5.自签署ICF开始至末次给药后的3个月内，受试者及其伴侣无生育计划且自愿采取有效避孕措施。

Inclusion criteria

1.. Understand the procedures of this research and voluntarily sign the informed Consent Form (ICF) in person; 2. Male or female individuals aged 18 or above at the time of signing the ICF; 3. The subjects have moderate to severe facial acne vulgaris and meet the following criteria: (1). The lesion may involve at least the face and other parts of the body; (2). Meeting the criteria for moderate to severe acne: the number of inflammatory nodules is >=5, accompanied by cysts or sinus tracts; (3).igga score: 4 points; 4.During the research period, the subjects must avoid using other methods for treating acne; 5. From the date of signing the ICF to within 3 months after the last administration, the subjects and their partners had no plans for having children and voluntarily adopted effective contraceptive measures;

排除标准：

1.对HB0043或HB0043中的任何成份过敏，或对生物制剂类药物过敏者或既往发生过严重药物过敏反应者。 2.受试者面部毛发过多，或者面部皮肤损伤或异常，可能会影响寻常痤疮的诊断或评估。 3.受试者患有除寻常痤疮之外的任何面部皮肤疾病。 4.筛选时受试者患有活动性自身免疫性疾病，包括但不限于银屑病、银屑病关节炎、类风湿关节炎、系统性红斑狼疮、炎症性肠病、葡萄膜炎等。 5.筛选时存在任何可能影响痤疮评估的其他活动性皮肤疾病或症状。 6.筛选前5年内存在淋巴增生性疾病或任何已知的恶性肿瘤病史（经治疗且认为已治愈的皮肤鳞状或基底细胞癌、宫颈原位癌或乳腺导管原位癌除外）。 7.感染相关排除标准（符合以下任意一条）： a)既往存在慢性或复发性感染病史者； b)筛选前6个月内有严重的危及生命的感染病史； c)研究者认为具有高感染风险的受试者（如存在腿部溃疡、留置导尿管、持续或复发性胸部感染等）； d)首次给药前2周内需要使用全身抗生素治疗的感染（普通感冒除外）。 8.结核病相关排除标准： 1)筛选时受试者病史、症状及相关检查结果提示患有活动性结核者； 2)γ-干扰素释放试验（IGRA）结果为阳性（如果受试者没有活动性结核病相关临床症状，且筛查时胸部CT检查结果研究者判断不会影响受试者用药安全性，允许入组）； 3)IGRA结果为不确定/可疑阳性者，允许进行一次复查，如果复查仍然可疑阳性/不确定，且筛查时胸部CT检查结果研究者判断不会影响受试者用药安全性，允许入组。 9.筛选前 3 个月内存在以下任何心脑血管疾病： a)中度至重度充血性心力衰竭（纽约心脏病协会 III 或 IV 级）； b)需要住院治疗的不稳定型心绞痛、心肌梗死、冠状动脉旁路移植术、经皮冠状动脉介入术（诊断性血管造影术除外）； c)需要住院的心房或心室性心律不齐、起搏器或除颤器植入； d)脑梗塞、脑出血、蛛网膜下腔出血或短暂脑缺血发作。 10.筛选时存在严重的基础疾病，如心脏、肺脏、肝脏、肾脏、血液、代谢、内分泌、消化、神经、精神或脑部等疾病，且经研究者评估不合适参与本研究的受试者。 11.筛选前 2 个月内或既往反复发作带状疱疹或单纯疱疹病史者。 12.筛选或基线时存在以下任意一种异常实验室检查结果： a)血生化：天冬氨酸氨基转移酶（AST）或丙氨酸氨基转移酶（ALT）或总胆红素（TBIL）＞2倍正常值上限（ULN）； b)血常规：血红蛋白（Hb）浓度男性＜85 g/L，女性＜80 g/L）； c)传染病筛查：乙肝表面抗原（HBsAg）、丙型肝炎抗体（HCV-Ab）、人类免疫缺陷病毒抗体（HIV-Ab）、梅毒螺旋体抗体阳性； 注：若HBsAg阴性，乙肝核心抗体（HBc-Ab）阳性，则需做 HBV-DNA 定量检查，如定量结果大于正常值，则排除； 13.筛选前6个月内进行过或试验期间计划进行大型手术者。 14.首次给药前1个月内或5个半衰期（以两者中较长时间者为准）参加过任何药物或医疗器械临床试验者。 15.筛选前2个月内接种过减毒活疫苗或研究期间有计划接种减毒活疫苗者。 16.筛选前6个月内有药物滥用史或过量饮酒史。 17.妊娠、哺乳期女性或计划妊娠者（包括男、女性）。 18.妊娠试验结果为阳性者。 19.试验期间及试验结束后的3个月内无法实行避孕措施者。 20.研究者认为不适合参加本临床试验的其他情况。

Exclusion criteria：

1. Those who are allergic to HB0043 or any of its components, or are allergic to biological agents, or have had severe drug allergic reactions in the past; 2. Excessive facial hair, or facial skin damage or abnormalities in the subjects may affect the diagnosis or assessment of acne vulgaris; 3. The subject has any facial skin disease other than acne vulgaris; 4. At the time of screening, the subjects had active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, uveitis, etc; 5. Any other active skin diseases or symptoms that may affect the assessment of acne were present during the screening process; 6. There was a history of lymphoproliferative disorders or any known malignant tumors within the five years prior to screening (except for treated and considered cured cutaneous squamous or basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast); 7. Infection-related exclusion criteria (meeting any one of the following) : (1) Those with a history of chronic or recurrent infections; (2) There is a history of severe life-threatening infections within 6 months prior to screening; (3) Subjects that researchers consider to have a high risk of infection (such as those with leg ulcers, indwelling urinary catheters, persistent or recurrent chest infections, etc.); (4) Infections (excluding the common cold) that require systemic antibiotic treatment within 2 weeks prior to the first administration. 8. Exclusion criteria related to tuberculosis: (1) Those whose medical history, symptoms and relevant examination results suggest active tuberculosis during screening; (2) If the result of the interferon - γ release assay (IGRA) is positive (if the subject has no clinical symptoms related to active tuberculosis and the chest CT examination result during screening is judged by the researcher not to affect the safety of the subject's medication, enrollment is allowed); (3) For those with an IGRA result of uncertain or suspected positive, a re-examination is allowed. If the re-examination still shows a suspected positive or uncertain result and the researcher determines that the chest CT examination result during screening will not affect the safety of the subject's medication, they are allowed to be enrolled. 9. Any of the following cardiovascular and cerebrovascular diseases occurred within the three months prior to screening: (1) Moderate to severe congestive heart failure (New York Heart Association Class III or IV); (2) Unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, and percutaneous coronary intervention (excluding diagnostic angiography) that require hospitalization; (3) Atrial or ventricular arrhythmia requiring hospitalization, pacemaker or defibrillator implantation; (4) Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack. 10. Subjects who had serious underlying diseases at the time of screening, such as heart, lung, liver, kidney, blood, metabolic, endocrine, digestive, nervous, mental or brain diseases, and were assessed by the researchers as unsuitable to participate in this study; 11. Those with a history of recurrent herpes zoster or herpes simplex within two months prior to screening or in the past; 12. Any of the following abnormal laboratory test results exists during screening or baseline: (1) Blood biochemistry: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin (TBIL) > 2 times the upper limit of the normal value (ULN); (2) Blood routine: Hemoglobin (Hb) concentration < 85 g/L for men and < 80 g/L for women; (3) Infectious disease screening: Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody; Note: If HBsAg is negative and hepatitis B core antibody (HBc-Ab) is positive, HBV-DNA quantitative test is required. If the quantitative result is greater than the normal value, it is excluded. 13. Those who have undergone major surgeries within the 6 months prior to screening or are scheduled to undergo major surgeries during the trial period; 14. Those who have participated in any clinical trial of a drug or medical device within one month prior to the first administration or within five half-lives (whichever is longer); 15. Those who have received a live attenuated vaccine within two months prior to screening or those who plan to receive a live attenuated vaccine during the study period; 16. There is a history of drug abuse or excessive alcohol consumption within 6 months prior to screening; 17. Pregnant, lactating women or those planning to become pregnant (including both men and women); 18. Those whose pregnancy test results are positive; 19. Those who are unable to take contraceptive measures during the trial period and within three months after the trial ends; 20. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.

研究实施时间：

Study execute time：

从 From 2026-03-15 00:00:00至 To 2027-03-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-15 00:00:00 至 To 2026-09-15 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 14

Group：

Intervention Group

Sample size：

干预措施：

受试者自 W0 接受注射用 HB0043，300mg，皮下注射给药，给药频率为每 2 周 1 次（Q2W），W14 末次给药，末次访视为 W16

干预措施代码：

Intervention：

The subjects received hb0043300mg for injection from W0, and were administered subcutaneously once every two weeks (q2w). The last administration was at W14, and the last visit was at w16

Intervention code：

组别：

对照组

样本量：

 7

Group：

Control Group

Sample size：

干预措施：

受试者自W0接受安慰剂，皮下注射给药，频率为Q2W；自W8开始，接受注射用HB0043，300mg，皮下注射给药，给药频率为Q2W，W14末次给药，末次访视为W16。

干预措施代码：

Intervention：

The subjects received placebo from W0 by subcutaneous injection at a frequency of Q2W. Starting from W8, HB0043 for injection, 300mg, was administered

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

  

Country：

China

Province：

Shandong

City：

单位(医院)：

 山东第一医科大学附属皮肤病医院 

单位级别：

 三级甲等 

Institution
hospital：

Shandong Provincial Institute of Dermatology and Venereology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

炎性病变计数

指标类型：

主要指标

Outcome：

Count of inflammatory lesions

Type：

Primary indicator

测量时间点：

16周

测量方法：

研究者计数

Measure time point of outcome：

16 weeks

Measure method：

Investigator counting

指标中文名：

治疗期间出现的不良事件（TEAE）的受试者发生比例（%）、性质、相关性和严重程度

指标类型：

次要指标

Outcome：

The proportion (%), nature, correlation and severity of adverse events (TEAE) that occurred during treatment in the subjects

Type：

Secondary indicator

测量时间点：

16周

测量方法：

医生评价/化验检查

Measure time point of outcome：

16weeks

Measure method：

Investigator's evaluation/Laboratory tests

指标中文名：

研究者总体评估评分

指标类型：

主要指标

Outcome：

Overall Investigator Assessment (IGA) score

Type：

Primary indicator

测量时间点：

16周

测量方法：

研究者评价

Measure time point of outcome：

16 weeks

Measure method：

Investigator Assessment

指标中文名：

炎性病变计数相对于基线的变化百分比

指标类型：

次要指标

Outcome：

Percentage change in inflammatory lesion count from baseline

Type：

Secondary indicator

测量时间点：

第16周

测量方法：

Measure time point of outcome：

Week 16

Measure method：

指标中文名：

IGA 评分较基线至少降低 2 分的受试者比例

指标类型：

次要指标

Outcome：

Proportion of subjects with IgA score at least 2 points lower than baseline

Type：

Secondary indicator

测量时间点：

第 2 周、第 4 周、第 8 周和第 12 周、第16周

测量方法：

Measure time point of outcome：

Week 2, 4, 8, 12, 16

Measure method：

指标中文名：

IGA 评分为“清除”或“几乎清除”的受试者比例

指标类型：

次要指标

Outcome：

Proportion of subjects with IgA score of "clearance" or "almost clearance"

Type：

Secondary indicator

测量时间点：

第 2 周、第 4 周、第 8 周和第 12 周、第16周

测量方法：

Measure time point of outcome：

Week 2, 4, 8, 12, 16

Measure method：

指标中文名：

痤疮生活质量相对于基线的变化

指标类型：

次要指标

Outcome：

Changes of acne quality of life relative to baseline

Type：

Secondary indicator

测量时间点：

第 16 周

测量方法：

Measure time point of outcome：

Week 16

Measure method：

指标中文名：

IGA 评分为“清除”或“几乎清 除”且与基线 IGA 评分相比至少降低 2 分的受试者比例

指标类型：

次要指标

Outcome：

Proportion of subjects with IgA score of "clear" or "almost clear" and at least 2 points lower than baseline IgA score

Type：

Secondary indicator

测量时间点：

第 2 周、第 4 周、第 8 周和第 12 周、第16周

测量方法：

Measure time point of outcome：

Week 2, 4, 8, 12, 16

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由随机化统计师利用 SAS 软件（9.4或以上版本），采用区组随机化方法生成受试者随机分配表。随机过程使用的种子数和区组长度将作为保密数据记录并密封在盲底中，从而该受试者随机分配表具有重现性。采用信封法进行分配隐藏。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization statistician used SAS software (version 9.4 or above) and adopted the block randomization method to generate the random assignment table of the subjects. The number of seeds and the block length used in the random process will be recorded as confidential data and sealed in a blind background, thus ensuring the reproducibility of the random assignment table for the subjects. The envelope method is adopted for allocation and concealment.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

对研究参与者、研究者设盲

Blinding：

Blinding research participants and researchers

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不适用

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not Applicable

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究采用电子数据采集（EDC）系统进行研究数据的采集。对指定的研究相关人员进行EDC系统培训。相关人员接受过培训后，获取相应权限账号可登录EDC系统，按照eCRF填写指南的要求，将数据录入eCRF中。EDC系统自动核查eCRF中的数据并产生相应提示信息，允许研究人员对录入的数据进行修改，最后主要研究者或其授权的研究人员进行电子签名。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

In this study, the Electronic Data Acquisition (EDC) system was adopted to collect research data. Conduct EDC system training for the designated research-related personnel. After receiving training, relevant personnel can obtain the corresponding permission account to log in to the EDC system and enter the data into the eCRF in accordance with the requirements of the eCRF filling guide. The EDC system automatically checks the data in the eCRF and generates corresponding prompt information, allowing researchers to modify the entered data. Finally, the principal researcher or the researcher authorized by him/her signs electronically.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-03-10 17:47:03