ChiCTR2500095375 版本V1.0 版本创建时间2025/01/07 08:48:15 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：

ChiCTR2500095375 

最近更新日期：

Date of Last Refreshed on：

2025-01-07 08:47:37 

注册时间：

Date of Registration：

2025-01-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

注射用HB0043在中度至重度化脓性汗腺炎患者中的剂量递增单中心临床研究

Public title：

Single-center clinical trial of dose escalation of HB0043 for injection in subjects with moderate-to-severe hidradenitis suppurativa

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项开放标签和剂量递增、评估HB0043 (IL17A/IL36R双抗)在成人中度至重度化脓性汗腺炎患者中的安全性和疗效的的I/II期临床研究

Scientific title：

An open-label, dose-escalation, phase I/II study evaluating the safety and efficacy of HB0043 (dual antibody IL17A/IL36R) in adults with moderate-to-severe hidradenitis suppurativa

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：

+86 156 8969 7710

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：

山东省济南市经十路27397号

研究负责人通讯地址：

济南市槐荫区经十路27397号

Applicant address：

27397 Jingshi Road, Jinan 250022, Shandong Province

Study leader's address：

Jingshi Road, Jinan 27397, China.

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, Shandong First Medical University

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 Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

20241223IIT002

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：

2024-12-23 00:00:00

伦理委员会联系人：

赵伟

Contact Name of the ethic committee：

Wei Zhao

伦理委员会联系地址：

济南市槐荫区经十路27397号

Contact Address of the ethic committee：

Jingshi Road, Jinan 27397, 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 Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences

研究实施负责（组长）单位地址：

济南市槐荫区经十路27397号

Primary sponsor's address：

Jingshi Road, Jinan 27397, 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

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：

济南市槐荫区经十路27397号

Institution
hospital：

Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences

Address：

Jingshi Road, Jinan 27397, China.

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Subject of your choice (self-supporting)

Target disease：

Hidradenitis suppurativa

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期+II期 

Study phase：

1-2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

本研究的目的是评价注射用HB0043静脉给药在中度至重度化脓性汗腺炎受试者中的安全性及耐受性，同时评价注射用HB0043静脉给药在中度至重度化脓性汗腺炎受试者中的初步有效性。  

Objectives of Study：

The aim of this study was to evaluate the safety and tolerability of intravenous HB0043 for injection in subjects with moderate-to-severe hidradenitis suppurativa, and to evaluate the preliminary efficacy of intravenous HB0043 for injection in subjects with moderate-to-severe hidradenitis suppurativa.

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. 筛选前化脓性汗腺炎（HS）病史≥6个月；
4. 须满足中度至重度HS定义，同时满足以下3个条件：(1)病变至少出现在2个不同的解剖区域；(2)其中一个区域必须至少为Hurley II级或III级；(3)脓肿和炎性结节总数≥3个；
5. 给药前需接受口服抗生素治疗HS，满足给药前4周内给药剂量和给药频率不变，且试验期间给药剂量和给药频率不变；
6. 受试者必须同意在试验期间每天在病灶处使用一种非处方杀菌剂（氯已定、过氧化苯甲酰等）；
7. 自签署ICF开始至末次给药后的6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 study procedure and sign an informed consent form (ICF) in person; 2. Male or female >=18 years old at the time of signing the ICF; 3. Pre-screening history of suppurative hidradenitis (HS) >=6 months; 4. The definition of moderate to severe HS must be met, and the following three conditions must be met: 1) The lesions were present in at least 2 different anatomic regions; 2) One of the areas must be at least Hurley Level II or III; 3) The total number of abscesses and inflammatory nodules was >=3; 5. Oral antibiotic therapy for HS should be taken before administration, and the dose and frequency of administration should be unchanged within 4 weeks before administration, and the dose and frequency of administration should be unchanged during the trial; 6. Subjects must agree to use an over-the-counter fungicide (chlorhexidine, benzoyl peroxide, etc.) at the lesion site daily during the trial period; 7. Within 6 months from the date of signing the ICF to the last dose, the subject and his/her partner are not planning to have children and are voluntarily using effective contraceptive methods.

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曾发生过严重药物过敏反应者； 2. 基线时瘘管总数≥20个； 3. 筛选时存在除HS以外的其他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； 4. 筛选时存在任何可能影响HS评估的其他活动性皮肤疾病或症状； 5. 筛选访视前5年内存在淋巴增生性疾病或任何已知的恶性肿瘤病史； 6. 感染相关排除标准； 1) 既往存在慢性或复发性感染病史者；2) 筛选前 6 个月内有严重的危及生命的感染病史；3) 研究者认为受试者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）；4) 给药前 2 周内存在除 HS 外需要使用全身抗生素治疗的感染（普通感冒除外）； 7. 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 8. 筛选前3个月内存在心脑血管疾病，中度至重度充血性心力衰竭（纽约心脏病协会 III 或 IV 级）；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）；需要住院的心房或心室性心律不齐、起搏器或除颤器植入；脑梗塞、脑出血、蛛网膜下腔出血或短暂脑缺血发作； 9. 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； 10. 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； 11. 筛选时患者存在具有临床意义的心电图异常，经研究者判断可能会造成风险； 12. 筛选或基线时存在以下异常实验室检查结果：(1) 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）； (2) 血常规：血红蛋白（Hb）浓度男性＜85 g/L，女性＜80 g/L）；(3) 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； 13. 既往接受过生物免疫调节剂及其生物类似药、非生物免疫调节剂以及皮质类固醇激素治疗，未满足相应洗脱期的； 14. 给药前2周内服用阿片类镇痛药者； 15. 筛选前6个月内进行过或试验期间计划进行大型手术者； 16. 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； 17. 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； 18. 曾有酒精或药物滥用史或证据； 19. 正处于妊娠中、哺乳期者； 20. 研究者认为不适合参加本临床试验的其他情况；

Exclusion criteria：

1. Allergic to HB0043 or any component in HB0043, or allergic to biologics, or have had a severe drug allergic reaction in the past; 2. Total number of fistulas at baseline ≥20; 3. Presence of other active autoimmune diseases other than HS at screening, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, uveitis, etc; 4. There are any other active skin diseases or symptoms that may affect the HS assessment at the time of screening; 5. Screening for a history of lymphoproliferative disease or any known malignancy in the 5 years prior to the visit (except for treated squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast that is considered cured); 6. Infection-related exclusion criteria (meet any of the following conditions) : 1) Patients with a history of chronic or recurrent infection; 2) A history of serious life-threatening infection within 6 months prior to screening; 3) Subjects who are considered by the investigator to have a high risk of infection (e.g. leg ulcers, indwelling catheters, persistent or recurrent chest infections, etc.); 4) Infections other than HS that require treatment with systemic antibiotics (other than the common cold) are present within 2 weeks prior to administration. 7. TB related exclusion criteria: 1) The medical history, symptoms and related test results of the subjects indicated active tuberculosis during screening; 2) The IGRA results are positive (if the subject has no clinical symptoms related to active TB and the results of chest CT examination at the time of screening do not affect the drug safety of the subject, admission is allowed); 3) If the IGRA result is uncertain/suspiciously positive, one review is allowed. If the review is still suspiciously positive/inconclusive, and the results of chest CT examination during screening will not affect the drug safety of the subjects, they are allowed to be enrolled; 8. Present witfarch any of the following cardiovascular and cerebrovascular diseases in the 3 months prior to screening: moderate to severe congestive heart failure (New York Heart Association Class III or IV); 1).Unstable angina requiring hospitalization, myocardial intion, coronary artery bypass grafting, percutaneous coronary intervention (except diagnostic angiography);2).Atrial or ventricular arrhythmia requiring hospitalization, pacemaker or defibrillator implantation;3).Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack; 9. Participants with serious underlying diseases, such as heart, lung, liver, kidney, blood, metabolic, endocrine, digestive, neurological, psychiatric, or brain diseases, who have been assessed by the investigator as unsuitable for participation in this study; 10. Patients with a history of recurrent herpes zoster or herpes simplex within 2 months before screening or in the past; 11. There were clinically significant electrocardiogram abnormalities in the patients during screening, which may pose risks according to the investigators; 12. Any of the following abnormal laboratory findings are present at screening or baseline: 1) Blood biochemistry: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin (TBIL) > 2 times the upper limit of normal (ULN); 2) Blood routine: hemoglobin (Hb) concentration for male < 85 g/L, female < 80 g/L); 3) Infectious disease screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody positive; 4.Note: If HBsAg is negative and HBc-Ab is positive, HBV-DNA quantitative test should be performed. If the quantitative result is greater than the normal value, HBV-DNA will be excluded. 13. Those who have received the following drugs in the past and have not met the corresponding eluting period (not listed are eluted according to 5 drug half-lives);5.Drug class time limit Biological immunomodulators and their biosimilars: 12 weeks or 5 half-lives before administration of adalimumab, Infliximab, ulinumab, Anabucin, Natalizumab, etc. (whichever is longer) Other abiotic immune modulators Such as methotrexate (MTX), cyclosporine A, tretinoin, Apast, thalidomide, colchicine and so on 4 weeks before administration other Corticosteroid hormones such as prednisone are administered 4 weeks before Topical use of corticosteroid hormones 3 days before administration 14. People who have taken opioid analgesics within 2 weeks prior to administration; 15. Patients who had undergone major surgery within 6 months prior to screening or planned to undergo major surgery during the trial; 16. Participants in clinical trials of any drug or medical device within 1 month prior to administration or within 5 half-lives, whichever is longer; 17. Persons who had received live attenuated vaccine within 2 months before screening or who had planned to receive live attenuated vaccine during the study period; 18. A history or evidence of alcohol or drug abuse; 19. Those who are pregnant or breastfeeding; 20. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-02-01 00:00:00 至 To 2026-01-01 00:00:00  

干预措施：

Interventions：

组别：

低剂量组

样本量：

4

Group：

low dose group

Sample size：

干预措施：

HB0043 30mg

干预措施代码：

Intervention：

HB0043 30mg

Intervention code：

组别：

高剂量组

样本量：

4

Group：

High dose group

Sample size：

干预措施：

HB0043 100mg

干预措施代码：

Intervention：

HB0043 100mg

Intervention code：

组别：

中剂量组

样本量：

4

Group：

Middle dose group

Sample size：

干预措施：

HB0043 50mg

干预措施代码：

Intervention：

HB0043 50mg

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

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 Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Venerology, Shandong First Medical University & Shandong Academy of Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

24周时患者的安全性

指标类型：

主要指标

Outcome：

Safety In 24 weeks

Type：

Primary indicator

测量时间点：

24周

测量方法：

24周时患者发生不良反应的数量和种类

Measure time point of outcome：

Week 24

Measure method：

Description analysis

指标中文名：

16周时患者达到HiSCR75的比例

指标类型：

次要指标

Outcome：

HiSCR75 On 24 weeks of patients

Type：

Secondary indicator

测量时间点：

16周

测量方法：

基于HiSCR评分，16周时患者达到HiSCR75的比例

Measure time point of outcome：

Week16

Measure method：

Based on HiSCR index, Doctor assessment of percentage of HiSCR75

指标中文名：

16周时皮损脓肿、炎性结节、引流性瘘管计数减少量

指标类型：

次要指标

Outcome：

counts of Abscesses, inflammatory nodule and tunnels on 16 weeks

Type：

Secondary indicator

测量时间点：

16周

测量方法：

研究者评价对16周时脓肿和炎性结节总数、脓肿、炎性结节、引流性瘘管的计数

Measure time point of outcome：

16 weeks

Measure method：

counts of Abscesses, inflammatory nodule and tunnels

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

皮肤

组织：

Sample Name：

lesion

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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）：

无

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

None

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

无

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

None

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：

本研究的采集将使用专门设计的病例收集表，之后录入山东第一医科大学附属皮肤病医院患者信息管理系统内进行统一保存和管理。

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

Data will be collected using specially designed case collection forms, which will subsequently be entered into the Patient Information Management System at the Hospital for Skin Diseases, Shandong First Medical University for standardized storage and management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-01-07 08:47:37