Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis

NCT05407246 | Completed Phase 2

• 1 other identifier: HM005AS2S01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 11

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period(4-week), treatment period(16-week) and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment. Main purpose: The efficacy of hemay005 tablet in the treatment of active ankylosing spondylitis (as) was evaluated by placebo parallel control. Secondary purpose:

• To evaluate the safety of oral hemay005 tablets in patients with active as.
• To evaluate the population pharmacokinetics of hemay005 tablets in patients with active as.

Conditions

Active Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• ASAS20

  The proportion of subjects who achieved ASAS 20 remission at the week 16，higher proportion means better effecacy of Hemay005.

  week 16

Secondary Outcomes (10)

• BASFI

  week 2, 4, 8, 12 and 16

• BASDAI

  week 2, 4, 8, 12 and 16

• ASAS20

  week 2, 4, 8, 12

• ASAS40

  week 2, 4, 8, 12 and 16

• ASQoL

  week 16

Study Arms (3)

Hemay005 75mg BID group

ACTIVE COMPARATOR

75mg BID of Hemay005; daily oral administrtion for 16 weeks

Drug: Hemay005

Hemay005 60mg BID group

ACTIVE COMPARATOR

60mg BID of Hemay005; daily oral administrtion for 16 weeks

Drug: Hemay005

placebo group

PLACEBO COMPARATOR

Placebo of Hemay005; daily oral administrtion for 16 weeks

Drug: Hemay005

Interventions

Hemay005 DRUG

Hemay005 60 mg treatment group (group A): hemay005 tablets 60 mg bid were used during the treatment period; Hemay005 75 mg treatment group (group B): hemay005 75 mg bid was used during the treatment period; Placebo group (Group C): placebo (hemay005 tablet simulant) bid was used during the treatment period;

Also known as: placebo

Hemay005 60mg BID group; Hemay005 75mg BID group; placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign the informed consent form of this study.
• Aged between 18 and 65 years old (both ends included, subject to the date of signing the informed consent form), male or female.
• kg ≤ male weight \<100 kg, 45 kg ≤ female weight \<100 kg.
• The results of human leucocyte antigen (HLA) -b27 were positive.
• Be able to comply with the follow-up schedule and other protocol requirements
• As (revised New York standard 1984) was diagnosed as follows:
• Low back pain lasted for at least 3 months. The pain improved with activity, but the rest did not reduce;
• The movement of lumbar vertebra in the direction of anteroposterior and lateral flexion was limited;
• The extension range of thorax was smaller than the normal value of the same age and sex;
• Bilateral sacroiliac arthritis grade II \~ IV, or unilateral sacroiliac arthritis grade III \~ IV.
• If the patient has 4) and adds any one of 1) \~3) respectively, it can be diagnosed as as;
• The subjects shall at least meet the requirements of 1) and 2) below:
• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4, and chronic low back pain ≥ 4 (patient back pain intensity assessment question 1) (NRS score);
• At least one nonsteroidal anti-inflammatory drugs (NSAIDs) was used before randomization, but the symptoms were not relieved or the drugs were intolerable or there were drug contraindications, that is, at least 4 weeks of stable use of 1 NSAID at the recommended dose or ≥ 2 NSAIDs, each NSAID was used stably for ≥ 2 weeks) or intolerable before randomization;
• In case of any of the following three criteria, the subject shall also meet the corresponding provisions:

You may not qualify if:

• Have the following diseases or disease history:
• Complete rigidity of spine or complete fusion of sacroiliac joint;
• Patients with a history of other rheumatic autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.);
• Patients with a history of tuberculosis or active tuberculosis (there are signs or symptoms of active tuberculosis judged by the researcher at the time of screening):
• If the patient has a previous history of tuberculosis and has been cured for at least 3 years before randomization according to the researcher's assessment, screening is allowed; Subjects with negative T-SPOT during screening can be included in this study. Subjects with positive T-SPOT in the screening period need to undergo tuberculosis related clinical examination (tuberculosis related clinical examination conducted within 12 weeks before randomization can be directly used for evaluation). If tuberculosis related clinical examination is confirmed as active tuberculosis, subjects cannot be selected for this study; If tuberculosis related clinical examination confirms inactive tuberculosis, the subject can be included in this study. If the research center is unable to carry out T-SPOT test, it can also accept tuberculosis screening with QuantiFERON TB gold test kit. The processing of QuantiFERON TB gold screening results is the same as that of T-SPOT;
• Patients with malignant tumor or any history of malignant tumor within 5 years before screening (except skin squamous cell carcinoma in situ, basal cell carcinoma or cervical carcinoma in situ after treatment and no recurrence evidence in the past 12 weeks);
• Evidence of active infection within 1 month before screening, including acute and chronic infection and local infection, such as sepsis, abscess, cellulitis and opportunistic fungal (such as Candida) infection (which can be judged by the research doctor in combination with the specific situation of the patient);
• Patients with severe basic diseases, such as heart, lung, kidney, liver, nerve, endocrine, gastrointestinal, metabolic or hematological diseases, moderate to severe congestive heart failure (New York Heart Association grade III or IV);
• Have a history of alcohol or drug abuse or dependence, or a history of mental illness;
• Situations that may affect the absorption of oral drugs, such as subtotal gastrectomy, clinically significant diabetes gastroenteropathy, or some types of weight loss surgery such as gastric bypass surgery, do not include operations that simply partition the stomach into a separate chamber, such as gastric banding surgery;
• Pregnant or lactating women;
• Those who are allergic or allergic to the study drug or its preparation components;
• Those who have undergone major surgery (including spinal surgery or joint surgery) within the first 6 months or plan to undergo major surgery during the trial;
• Those who have participated in clinical trials of any drugs or medical devices within the first three months of screening;
• Those who plan to receive attenuated or live vaccine during the test;

Sponsors & Collaborators

• Tianjin Hemay Pharmaceutical Co., Ltd: lead

Study Sites (11)

The First Affiliated Hospital of Bengbu Medical University

Hefei, Anhui, 233000, China

Location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The Third Affiliated Hospital of Sun Yat sen University

Guangzhou, Guangdong, 510275, China

Location

Hebei CNPC Central Hospital

Langfang, Hebei, 05001, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

Location

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology

Wuhan, Hubei, 430000, China

Location

Chenzhou first people's Hospital

Chenzhou, Hunan, 423099, China

Location

Pingxiang people's Hospital

Pingxiang, Jiangxi, 337099, China

Location

Jilin Provincial People's Hospital

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi’an, Shanxi, 71000, China

Location

MeSH Terms

Interventions

Hemay005

Study Officials

• Xiaofeng Zeng, M.D

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: August 5, 2022
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)