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Monoclonal Antibodies

Rozibafusp Alfa for Lupus

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 baseline, week 12, 24, 36, 44 and 52
Awards & highlights

Summary

This trial will test whether Rozibafusp Alfa is an effective treatment for lupus patients who are not responding well to current treatments.

Eligible Conditions
  • Lupus

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of patients achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at week 52
Secondary outcome measures
Annualized flare rate
Annualized moderate and severe flare rate
Annualized severe flare rate
+17 more

Side effects data

From 2020 Phase 1 trial • 34 Patients • NCT03156023
29%
Seasonal allergy
14%
Rash
14%
Colitis
14%
Animal bite
14%
Pruritus
14%
Bronchitis
14%
Musculoskeletal chest pain
14%
Invasive ductal breast carcinoma
14%
Deafness bilateral
14%
Photopsia
14%
Oedema
14%
Eye infection
14%
Fungal infection
14%
Influenza
14%
Sinusitis
14%
Upper respiratory tract infection
14%
Contusion
14%
Electrocardiogram abnormal
14%
Arthralgia
14%
Back pain
14%
Pain in extremity
14%
Rheumatoid arthritis
14%
Basal cell carcinoma
14%
Dizziness
14%
Headache
14%
Sciatica
14%
Anxiety
14%
Breast mass
14%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Rozibafusp Alfa 70 mg
Rozibafusp Alfa 140 mg
Rozibafusp Alfa 210 mg
Rozibafusp Alfa 420 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
1,392 Previous Clinical Trials
1,380,876 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,023 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
~45 spots leftby Jul 2025
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