NCT05430854 (RECAST SLE OLE) is a Phase 2 clinical trial of Daxdilimab in Systemic Lupus Erythematosus, sponsored by Amgen.

Who is sponsoring NCT05430854?

NCT05430854 is sponsored by Amgen.

What drugs are being tested in NCT05430854?

Interventions in NCT05430854: Daxdilimab.

What condition does NCT05430854 study?

NCT05430854 studies Systemic Lupus Erythematosus.

Is NCT05430854 still recruiting?

NCT05430854 is currently terminated. Last updated 19 September 2024.

Are results published for NCT05430854?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-19 · How we verify

NCT05430854: RECAST SLE OLE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

Terminated Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing Daxdilimab in Systemic Lupus Erythematosus in 155 participants. Terminated before completion.

Timeline

1 June 2022

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	155
Start date	1 June 2022
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	52 locations across Greece, Serbia, Taiwan, Poland, Mexico, Argentina, United States, Spain

Drugs / interventions tested

Daxdilimab — full drug profile →

Conditions studied

Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 72, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) Primary · Up to approximately 56 weeks

An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	25
Daxdilimab 200 mg Q4W in Parent Study	31
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	31

Number of Participants Who Experienced Serious Adverse Events (SAEs) Primary · Up to approximately 56 weeks

An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	3
Daxdilimab 200 mg Q4W in Parent Study	5
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	5

Number of Participants Who Experienced AEs of Special Interest (AESI) Primary · Up to approximately 56 weeks

An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	1
Daxdilimab 200 mg Q4W in Parent Study	2
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	1

Serum Concentration of Daxdilimab Secondary · Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56

Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.

Week 0

Group	Value	95% CI
Daxdilimab 200 mg Q4W in Parent Study	5.527	± 4.412
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0.458	± 0.614

Week 12

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0.291	± 0.390
Daxdilimab 200 mg Q4W in Parent Study	0.502	± 0.740
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0.400	± 0.520

Week 24

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0.414	± 0.575
Daxdilimab 200 mg Q4W in Parent Study	0.398	± 0.531
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0.437	± 0.437

Week 36

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0.508	± 0.616
Daxdilimab 200 mg Q4W in Parent Study	0.464	± 0.467
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	1.002	± 1.404

Week 48

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0.813	± 1.044
Daxdilimab 200 mg Q4W in Parent Study	0.380	± 0.395
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0.815	± 0.759

Week 56

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0.399	± 0.251
Daxdilimab 200 mg Q4W in Parent Study	0.146	± 0.009
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0.997	± 0.898

Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count Secondary · Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56

PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.

Week 0

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	70.59	± 225.39
Daxdilimab 200 mg Q4W in Parent Study	-58.37	± 36.19
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	-30.40	± 50.67

Week 12

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	1.33	± 142.08
Daxdilimab 200 mg Q4W in Parent Study	13.57	± 158.14
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	-21.25	± 66.97

Week 24

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	-14.39	± 164.63
Daxdilimab 200 mg Q4W in Parent Study	-24.98	± 79.85
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	-19.86	± 77.23

Week 36

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	13.64	± 255.67
Daxdilimab 200 mg Q4W in Parent Study	-41.36	± 41.29
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	-51.11	± 35.28

Week 48

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	-49.47	± 34.54
Daxdilimab 200 mg Q4W in Parent Study	-58.65	± 43.33
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	-4.44	± 74.93

Week 56

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	-75.22	± 14.11
Daxdilimab 200 mg Q4W in Parent Study	-43.13	± 49.49
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	4.15	± 96.43

Number of Participants Expressing Anti-drug Antibodies (ADA) Secondary · Up to approximately 56 weeks

ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.

ADA not detected

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	34
Daxdilimab 200 mg Q4W in Parent Study	48
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	44

ADA Incidence

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	7
Daxdilimab 200 mg Q4W in Parent Study	6
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	4

Only Baseline positive

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	0
Daxdilimab 200 mg Q4W in Parent Study	3
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	0

Only post-Baseline positive

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	6
Daxdilimab 200 mg Q4W in Parent Study	3
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	3

Both Baseline and post-Baseline positive

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	7
Daxdilimab 200 mg Q4W in Parent Study	3
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	2

Persistent positive

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	4
Daxdilimab 200 mg Q4W in Parent Study	3
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	2

Transient positive

Group	Value	95% CI
Placebo/Daxdilimab 200 mg Q12W	9
Daxdilimab 200 mg Q4W in Parent Study	3
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 56 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo/Daxdilimab 200 mg Q12W

Serious: 3/47 (6%)

Deaths: 0/47

Daxdilimab 200 mg Q4W in Parent Study

Serious: 5/57 (9%)

Deaths: 0/57

Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W

Serious: 5/51 (10%)

Deaths: 0/51

Serious adverse events (14 terms)

Reaction	System	Placebo/Daxdilimab 200 mg …	Daxdilimab 200 mg Q4W in P…	Daxdilimab 200 mg Q12W/Dax…
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—
Myocardial ischaemia	Cardiac disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Appendicitis	Infections and infestations	—	—	—
Cytomegalovirus nephritis	Infections and infestations	—	—	—
Dengue fever	Infections and infestations	—	—	—
Device related sepsis	Infections and infestations	—	—	—
Meningitis	Infections and infestations	—	—	—
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	—	—	—
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—
Glomerulonephritis minimal lesion	Renal and urinary disorders	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Placebo/Daxdilimab 200 mg …	Daxdilimab 200 mg Q4W in P…	Daxdilimab 200 mg Q12W/Dax…
Urinary tract infection	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Depression	Psychiatric disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—

Most-reported serious reactions: Iron deficiency anaemia, Pancytopenia, Myocardial ischaemia, Cholelithiasis, Appendicitis, Cytomegalovirus nephritis, Dengue fever, Device related sepsis.

Data from ClinicalTrials.gov NCT05430854 adverse events section.

Sponsor's own description

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Molecular Mechanisms Behind the Role of Plasmacytoid Dendritic Cells in Systemic Sclerosis.
Silva IS, Ferreira BH, Almeida CR. · · 2023 · cited 17× · PMID 36829561 · DOI 10.3390/biology12020285

Verify or expand the search:

Other trials of Daxdilimab

Trials testing the same drug.

NCT05669014 — A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis · Phase 2 · completed
NCT05540665 — Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) · Phase 2 · terminated
NCT05591222 — Study of Daxdilimab (HZN-7734) in Participants With Moderate-to-Severe Primary Discoid Lupus Erythematosus · Phase 2 · terminated
NCT05368103 — Study of DAXDILIMAB for the Treatment of Moderate-to-Severe Alopecia Areata · Phase 2 · completed

Other recruiting trials for Systemic Lupus Erythematosus

Currently open trials in the same condition.

NCT06984341 — A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in P · Phase 1 · recruiting
NCT07526350 — MTS109 in Patients With Refractory Autoimmune Diseases · EARLY_PHASE1 · recruiting
NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
NCT07371468 — A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD) · Phase 1 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05430854 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 19 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05430854.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing