Terminated/Withdrawn
Sponsor ID
HZNP-DAX-203

Study of Daxdilimab (HZN-7734) in Participants with Active Proliferative Lupus Nephritis (LN)

Sponsor ID
HZNP-DAX-203
Clinicaltrials.gov ID
NCT05540665
EUCTIS ID
N/A
EudraCT ID
2022-001377-31

Study Details

Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN).

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
19
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of participants achieving complete renal response (CRR) at Week 48 and sustained through Week 52.

Timeframe: Week 48 to Week 52

Secondary Outcome Measures

Proportion of participants achieving overall renal response (ORR) at Week 48 and sustained through Week 52.

Timeframe: Week 48 to Week 52

Change from baseline in estimated glomerular filtration rate (eGFR) at Week 52.

Timeframe: Day 1 to Week 52

Proportion of participants able to taper oral corticosteroids (OCS) to target by Week 24 and maintain target dose through Week 52.

Timeframe: Week 24 to Week 52

Anti-Drug Antibody (ADA) rate.

Timeframe: Day 1 to Week 116

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).

Timeframe: Day 1 to Week 116

Locations

Location
Status
Contact Us
Location
DaVita Clinical Research – El Paso
El Paso, Texas, United States, 79925
Status
Recruiting
Location
Care and Cure Clinic
Houston, Texas, United States, 77090
Status
Recruiting
Location
California Kidney Specialists
San Dimas, California, United States, 91773-3537
Status
Recruiting
Location
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
Warszawa, Poland, 04-141
Status
Recruiting
Location
University Clinical Center of Serbia - PPDS
Belgrade, Beograd, Serbia, 11000
Status
Recruiting
Location
Lady Davis Carmel Medical Center
Haifa, HaMerkaz, Israel, 3436212
Status
Recruiting
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