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A Study of LNK01001 Capsule in Moderately to Severely Active Rheumatoid Arthritis

NCT06099535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2023-10-25

No results posted yet for this study

Summary

This study includes two periods. In Period 1, Participants who meet eligibility criteria will be randomized in a 1:1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B or a matching placebo for 12 weeks. Participants who receive a placebo in Period 1 will be re-randomized at Week 13 in a 1:1 ratio to receive a twice-daily oral LNK01001 Dose A or LNK01001 Dose B for 12 weeks (period 2). Participants who receive LNK01001 ( Dose A and Dose B) in Period 1 will maintain the treatment dose in Period 2.

Conditions

Interventions

DRUG

LNK01001 Dose A

Capsules taken orally

DRUG

LNK01001 Dose B

Capsules taken orally

DRUG

placebo

Capsules taken orally

Sponsors & Collaborators

  • Lynk Pharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2022-12-29
Completion
2023-04-11

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099535 on ClinicalTrials.gov