QLS12010 in Participants With Moderate-to-severe Rheumatoid Arthritis

NCT07377773 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS12010-203
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this randomized, double-blind, placebo-controlled phase II clinical trial is to investigate the safety and efficacy of QLS12010 in subjects with moderate-to-severe rheumatoid arthritis.The main questions it aims to answer are: • Efficacy and safety of QLS12010 in participants with rheumatoid arthritis. Participants will be randomly allocated to four treatment groups at a 1:1:1:1 ratio to compare the efficacy and safety of different dosages of QLS12010 Capsules against the placebo.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.

  The DAS28-CRP score measures how active rheumatoid arthritis is. A score of 2.6 or lower indicates disease remission, while a greater score indicates more severe disease.

  12 weeks

Study Arms (4)

QLS12010 Capsule Dose 1 Group

EXPERIMENTAL

Drug: QLS12010

QLS12010 Capsule Dose 2 Group

EXPERIMENTAL

Drug: QLS12010

QLS12010 Capsule Dose 3 Group

EXPERIMENTAL

Drug: QLS12010

Placebo Group

PLACEBO COMPARATOR

Drug: placebo

Interventions

QLS12010 DRUG

QLS12010 oral capsule

QLS12010 Capsule Dose 1 Group; QLS12010 Capsule Dose 2 Group; QLS12010 Capsule Dose 3 Group

placebo DRUG

Matching placebo oral capsule

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (inclusive).
• Diagnosed with rheumatoid arthritis as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 12 weeks prior to screening; ACR functional class I-III.
• Tender joint count (TJC) ≥ 4/68 and swollen joint count (SJC) ≥ 4/66.
• High Sensitivity C-Reactive Protein (hsCRP) \> Upper Limit of Normal (ULN) or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h at screening.
• Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and one biologic disease-modifying antirheumatic drug (bDMARD)/ targeted synthetic disease-modifying antirheumatic drug (tsDMARD).
• Glucocorticoid dose ≤ 10 mg/day prednisone-equivalent, stable for ≥ 2 weeks pre-screening and ≥ 4 weeks pre-baseline.
• Nonsteroidal Antiinflammatory Drugs (NSAIDs) or acetaminophen, stable for ≥ 1 week pre-screening and ≥ 2 weeks pre-baseline.

You may not qualify if:

• Participants with other inflammatory arthritis, systemic inflammatory diseases, or Felty syndrome.
• Participants with a history of malignancy within 5 years prior to screening.
• Concurrent conditions predisposing to QT interval prolongation; QTc interval (Fridericia-corrected) \> 450 ms; or thyroid-stimulating hormone (TSH) \> 5 mIU/L.
• Participants with untreated recurrent migraine.
• Participants with a history of opportunistic infection within 6 months prior to ICF signing; any infection requiring hospitalization or IV anti-infective therapy within 3 months; or any acute systemic infection within 2 weeks prior to baseline.
• Participants with HIV, HBV, HCV, Treponema pallidum, or active tuberculosis (TB).
• Participants with a history of major surgery performed within 2 months prior to baseline.
• Participants with a history of severe allergic reactions or known allergy to any component of the study drug.
• Prior receipt of cell therapy (e.g., CAR-T) or T-cell engager therapy.
• Participants with a history of strong CYP3A4 inhibitors/inducers, narrow therapeutic index CYP3A substrates, strong P-gp/BCRP inhibitors, P-gp/BCRP substrates, or any QT-prolonging drugs within 4 weeks or 5 half-lives prior to baseline.
• Participants with a history of addictive drug abuse within 1 year prior to ICF signing; or alcohol abuse within 6 months prior to ICF signing.
• Participants with blood pressure \> 160/100 mmHg at baseline.
• Pregnant or lactating women.
• Participants with blood donation or total blood loss ≥ 400 mL within 3 months prior to ICF signing.
• Vaccination with or exposure to live/attenuated live vaccines within 4 weeks prior to screening.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

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

Central Study Contacts

Shuang Ye, PhD

CONTACT

021-58752345; Yeshuang@renji.com

Ting Li, PhD

CONTACT

021-58752345; Leeting007@163.com

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: January 22, 2026
• First Posted: January 30, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 5, 2028
• Study Completion (Estimated): June 5, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share