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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2026-05-22

No results posted yet for this study

Summary

This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN

Conditions

Interventions

DRUG

ianalumab s.c. q4w

ianalumab s.c. q4w in addition to SoC

DRUG

ianalumab s.c. q12w

ianalumab s.c. q12w in addition to SoC

DRUG

placebo s.c.

placebo s.c. q4w in addition to SoC

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2027-06-22
Completion
2031-02-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Czechia
  • Estonia
  • France
  • Germany
  • Guatemala
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Lithuania
  • Malaysia
  • Mexico
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05126277 on ClinicalTrials.gov