A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06406205
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Voclosporin（QL1074） — DRUG
    QL1074 23.7 mg BlD will be administered as a fixed dose without the use of therapeutic drugmonitoring. The protocol contains provisions for management of dose based on safety concerns, in particular, BP and renal function，can be managed by dose reduction and temporary of QL1074 to interruption.
  • Placebo — DRUG
    Placebo softgel capsules, identical to 7.9 mg QL1074, will be provided. The administration plan and dosage management regulations are the same as QL1074.

Study Details

The purpose of this study is to assess the efficacy of QL1074 compared with placebo in achieving renal response after 52 weeks of therapy in subjects with Active Lupus Nephritis.

Key Dates

Start date
Dec 25, 2023
Status verified
May 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Voclosporin（QL1074）
    oral, 23.7 mg twice daily (BID)，52 weeks Drug: Voclosporin calcineurin inhibitor Other Names: QL1074
  • Placebo Comparator: Placebo Oral Capsule
    Voclosporin placebo, oral, 3 capsules twice daily (BID)，52 weeks Drug: Placebo Oral Capsule matching placebo capsule

Primary Outcome Measure

Number of Participants With Complete Renal Remission at Week 52 [ Time Frame: Week 52 ]

Central Contacts

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