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Monoclonal Antibodies

Rozibafusp Alfa for Systemic Lupus Erythematosus

Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, 24, 36, 44, and 52

Summary

This trial is testing Rozibafusp Alfa to see if it can help patients with active SLE who haven't improved with standard treatments. The medication works by calming the overactive immune system. Rozibafusp Alfa is a new treatment being tested for systemic lupus erythematosus (SLE).

Eligible Conditions
  • Systemic Lupus Erythematosus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, 24, 36, 44, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, 24, 36, 44, and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With a SLE Responder Index (SRI-4) Response at Week 52
Secondary study objectives
Annualized Flares Rate Over 52 Weeks as Measured by BILAG Score Designation of "Worse" or "New" Resulting in a B-Score In ≥ 2 Organs or an A-Score in ≥ 1 Organ
Annualized Moderate and Severe Flare Rate Over 52 Weeks as Measured by Safety of Estrogens in Systemic Lupus Erythematosus National Assessment [SELENA] -Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] Flare Index (SFI)
Annualized Severe Flare Rate Over 52 Weeks as Measured by SFI
+21 more

Side effects data

From 2023 Phase 2 trial • 244 Patients • NCT04058028
22%
COVID-19
15%
Urinary tract infection
9%
Nasopharyngitis
9%
Upper respiratory tract infection
9%
Headache
7%
Pruritus
6%
Injection site reaction
6%
Back pain
6%
Dizziness
5%
Arthralgia
5%
Pyrexia
5%
Bronchitis
5%
Diarrhoea
3%
Hypertension
1%
Injection site erythema
1%
Uterine leiomyoma
1%
Rash
1%
Abdominal pain
1%
Nephrotic syndrome
1%
Iron deficiency anaemia
1%
COVID-19 pneumonia
1%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Rozibafusp Alfa 420 mg
Rozibafusp Alfa 70 mg
Rozibafusp Alfa 280 mg

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Rozibafusp Alfa, Dose CExperimental Treatment1 Intervention
Investigational product solution in vial
Group II: Rozibafusp Alfa, Dose BExperimental Treatment1 Intervention
Investigational product solution in vial
Group III: Rozibafusp Alfa, Dose AExperimental Treatment1 Intervention
Investigational product solution in vial
Group IV: Placebo for Rozibafusp AlfaPlacebo Group1 Intervention
Placebo Investigational product solution in vial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rozibafusp Alfa
2017
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,394,898 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
939,070 Total Patients Enrolled
~42 spots leftby Nov 2025
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