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Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Discoid Lupus Erythematosus Clinical Trial

Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Efficacy and Safety of Daxdilimab Subcutaneous Injection in Reducing Disease Activity in Adult Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Clinical Trial Summary

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

Clinical Trial Description

Approximately 99 participants will be enrolled to receive daxdilimab or placebo administered subcutaneously once every four weeks (Q4W) from Day 1 to Week 44. After week 24 all subjects will be receiving daxbilimab, including those assigned to the placebo arm, Q4W from Week 24 to Week 44. The maximum trial duration per participant is approximately 60 weeks including screening, the 48 weeks for the treatment period where participants will receive daxdilimab or placebo, and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study. Acquired from Horizon in 2024. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05591222
Study type Interventional
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Status Recruiting
Phase Phase 2
Start date October 12, 2022
Completion date December 2024
View Details
See also
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Completed NCT00001680 - A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus Phase 2
Completed NCT00625521 - Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions Phase 2
Completed NCT04908280 - Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus Phase 2
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Completed NCT05362188 - Topical Nicotinamide in Treatment of DLE Early Phase 1
Completed NCT00708916 - Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients Phase 1/Phase 2
Terminated NCT03958955 - Efficacy and Safety of Delgocitinib Cream in Discoid Lupus Erythematosus. Phase 2
Terminated NCT03159936 - Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Early Phase 1
Completed NCT00691769 - Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia
Completed NCT00608673 - Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus N/A
Recruiting NCT06261021 - Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus Phase 2
Completed NCT00625157 - Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2) Phase 2