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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

Study 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%
Animal bite
14%
Colitis
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
1,370 Previous Clinical Trials
1,377,444 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,887 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Rozibafusp Alfa for use?

"Taking into account the fact that Rozibafusp Alfa is in Phase 2 of its medical trials, Power's team concluded a safety assessment score of 2. This indicates some evidence of safety but no proven efficacy yet."

Answered by AI

How many volunteers are partaking in this research endeavor?

"To conduct this research, Amgen requires 320 eligible participants. Two of the sites where it will be hosted are Austin Regional Clinic Specialty Research in Texas and Penn State Milton South Hershey Medical Center in Pennsylvania."

Answered by AI

Are seniors being included in the recruitment process for this trial?

"Qualified applicants for this trial must be between the ages of 18 to 75. However, there are special studies available for participants who fall below or above those age brackets with a total of 18 and 104 respectively."

Answered by AI

Does this experiment still require participants to join?

"Right. The information hosted on clinicaltrials.gov suggests that this research project, which was initially posted on February 19th 2020, is currently enrolling recruits. 320 participants are being hunted across 42 different locations."

Answered by AI

At what venues is this research investigation being conducted?

"The current clinical trial is based out of Austin Regional Clinic Specialty Research in Texas, Penn State Milton South Hershey Medical Center in Pennsylvania, and Southwest Rheumatology in South carolina. Furthermore, there are 42 other enrolment sites involved with this research program."

Answered by AI

Is it possible to partake in this research project?

"This clinical trial is recruiting 320 participants with systemic lupus erythematosus aged between 18 and 75. Primarily, applicants must fulfil the following criteria: sign informed consent prior to participation; possess alopecia without scarring or conditions such as Alopecia areata/Androgenic Andropause; a valid age range (18-75); meet European League Against Rheumatism/American College of Rheumatology classification for SLE along with antinuclear antibodies ≥ 1:80 from Hep-2 cell sample at screening; have hybrid SLEDAI score > 6 and Clinical hSL"

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
2020. "Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04058028.
~47 spots leftby Apr 2025
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