A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis

NCT05849727 | Terminated Phase 2

• 1 other identifier: TQH3821-II-01
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 34

Brief Summary

To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20 (ACR20) improvement

  Proportion of patients with ACR20 at week 12.

  Evaluated at week 12.

Secondary Outcomes (13)

• American College of Rheumatology 20 (ACR20) improvement

  Evaluated at week 4, 8, 18, and 24.

• American College of Rheumatology 50 (ACR50) improvement

  Evaluated at week 4, 8, 12, 18, and 24.

• C-reactive protein (CRP)

  Evaluated at week 4, 8, 12, 18, and 24.

• Erythrocyte sedimentation rate (ESR)

  Evaluated at week 4, 8, 12, 18, and 24.

• 66 joint swelling counts (SJC)

  Evaluated at week 4, 8, 12, 18, and 24.

Study Arms (2)

TQH3821 tablets 200 mg

EXPERIMENTAL

Oral administration of TQH3821 tablets 200 mg, twice a day for 24 weeks.

Drug: TQH3821 tablets 200 mg

TQH3821 tablets matching placebo

PLACEBO COMPARATOR

The placebo group was taken orally until the end of week 12. At the end of week 12, the placebo group was switched to the oral administration of TQH3821 tablets 200 mg until the end of week 24.

Drug: TQH3821 tablets 200 mg; Drug: TQH3821 tablets matching placebo

Interventions

TQH3821 tablets 200 mg DRUG

TQH3821 is a Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor.

TQH3821 tablets 200 mg; TQH3821 tablets matching placebo

TQH3821 tablets matching placebo DRUG

TQH3821 tablets matching placebo without active substance.

TQH3821 tablets matching placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in this study and sign informed consent;
• Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
• The diagnosis meets the rheumatoid arthritis (RA) classification criteria jointly established by the American College of Rheumatology (ACR) and the European Alliance against Rheumatism (EULAR) in 2010, for at least 3 months ;
• Moderate to severe active RA was defined by the following criteria: joint swelling ≥6 (based on 66 joints), joint tenderness ≥6 (based on 68 joints), Disease activity score 28-C-reactive protein (DAS28-CRP) ≥3.2, and CRP\>10mg/L or erythrocyte sedimentation rate (ESR) \>28mm/h;
• At least 12 weeks of treatment with methotrexate (dose 7.5 to 25 mg/ week) and stable dose (7.5 to 25 mg/ week) ≥4 weeks prior to initial administration of the study drug (oral stable dose methotrexate will be continued as background therapy during the trial);
• The subjects can attend the study visit on time and complete the visit;

You may not qualify if:

• weeks before baseline examination, subjects underwent joint surgery or received intraarticular glucocorticoid therapy at the joint sites evaluated in this study;
• Patients with rheumatoid arthritis with joint functional activity grade Ⅳ or confined to a wheelchair or bed;
• Current or previous inflammatory joint diseases other than RA and other autoimmune venereal diseases;
• Patients with lung diseases deemed unsuitable for the study by the investigator;
• Cardiovascular and cerebrovascular abnormalities;
• Abnormal thyroid function;
• Subjects with a history or suspected demyelinating disease of the central nervous system;
• Have any type of active malignant tumor or have a history of malignant tumor;
• Presence of active Mycobacterium tuberculosis (TB) infection or latent TB infection without appropriate treatment;
• Have any acute or chronic active infectious disease;
• There are serious poorly controlled diseases;
• People with active hepatitis, or hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) antibody-positive;
• History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening, and positive antibodies to treponema pallidum during screening;
• Subjects who had suffered a severe trauma, fracture, or surgical procedure within 8 weeks prior to screening, or who were expected to require major surgical procedures during the study period;
• Female subjects who are pregnant or lactating;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (34)

Bozhou People's Hospital

Bozhou, Anhui, 236804, China

Location

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100041, China

Location

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The Southwest Hospital of AMU

Chongqing, Chongqing Municipality, 400038, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, 530016, China

Location

Hebei Provincial People's Hospital

Shijiazhuang, Hebei, 050051, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

The First Hospital of Qiqihar

Qiqihar, Heilongjiang, 161005, China

Location

Anyang District Hospital of Puyang City

Anyang, Henan, 455000, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

Location

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450053, China

Location

Shiyan Renmin Hospital

Shiyan, Hubei, 442000, China

Location

Xiangya Third Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 211100, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Jilin Provincial People's Hospital

Changchun, Jilin, 130021, China

Location

China-japan Friendship Hospital of Jilin University

Changchun, Jilin, 130033, China

Location

Central Hospital of Jinzhou

Jinzhou, Liaoning, 121000, China

Location

Heze Municipal Hospital

Heze, Shandong, 274000, China

Location

Yantaishan Hospital of Yantai

Yantai, Shandong, 264003, China

Location

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, 277100, China

Location

Tongji Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, 046000, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

The First Affiliated Hospital of PLA Air Force Medical University

Xi’an, Shanxi, 710000, China

Location

Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

Location

Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Wenling First People's Hospital

Taizhou, Zhejiang, 317500, China

Location

Taizhou Central Hospital Taizhou University Hospitai

Taizhou, Zhejiang, 318000, China

Location

Yuyao People's Hospital

Yuyao, Zhejiang, 315400, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: August 30, 2023
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 20, 2025

Record last verified: 2024-04

Locations

CN (34)