Rozibafusp Alfa for Lupus Erythematosus, Systemic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lupus Erythematosus, Systemic+1 More
Rozibafusp Alfa - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 Erythematosus, Systemic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 27 Secondary · Reporting Duration: Baseline, Week 12, 24, 36, 44 and 52

52 Weeks
Serum Rozibafusp Alfa trough concentrations
52 weeks
Annualized flare rate
Annualized moderate and severe flare rate
Annualized severe flare rate
Number of Subjects with significant changes in laboratory values
Number of Subjects with significant changes in vital signs
Number of patients with significant changes in laboratory values
Number of patients with significant changes in vital signs
Patient incidence of Serious adverse events
Therapeutic procedure
Rozibafusp Alfa terminal elimination half-life, if possible
Subject incidence of Serious adverse events
Subject incidence of Treatment-Emergent Adverse Events
Week 12
Lupus Quality of Life (QoL) score and change from baseline
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) mental component score individual domains change from baseline
Medical Outcomes Short Form 36 version 2 Questionnaire (SF-36v2) physical component score change from baseline
Medical Outcomes Short Form 36 version 2 Questionnaire (SF36v2) score change from baseline
Patient Global Assessment (PtGA) score change from baseline
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS-Fatigue SF7A) score change from baseline
Week 12
Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with a CLASI activity score ≥ 8 at baseline
Total tender and swollen joint count (limited to hands and wrists): ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with ≥ 6 tender and swollen joints in the hands and wrists at baseline
Total tender and swollen joint count ≥ 50% improvement from baseline at week 12, 24, 36, and 52 in subjects with ≥ 6 tender and swollen joints involving the hands and wrists at baseline
Week 24
Percent of patients achieving a SRI-4 response at week 24
Week 52
Percent of patients achieving The British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment (BICLA) index responses
Percent on patients achieving The British Isles Lupus Assessment Group (BILAG) based Combined Lupus Assessment (BICLA) index responses
Week 52
Percent of patients achieving Lupus Low Disease Activity State (LLDAS) at week 52
Percent of patients achieving Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response at week 52
SRI-4 at week 52 with reduction of OCS to less than or equal to 7.5 mg/day by week 44 and sustained through week 52 in subjects with a baseline OCS dose ≥ 10 mg/day

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Rozibafusp Alfa, Dose B
1 of 4
Rozibafusp Alfa, Dose C
1 of 4
Rozibafusp Alfa, Dose A
1 of 4
Placebo for Rozibafusp Alfa
1 of 4

Experimental Treatment

Non-Treatment Group

320 Total Participants · 4 Treatment Groups

Primary Treatment: Rozibafusp Alfa · Has Placebo Group · Phase 2

Rozibafusp Alfa, Dose B
Drug
Experimental Group · 1 Intervention: Rozibafusp Alfa · Intervention Types: Drug
Rozibafusp Alfa, Dose C
Drug
Experimental Group · 1 Intervention: Rozibafusp Alfa · Intervention Types: Drug
Rozibafusp Alfa, Dose A
Drug
Experimental Group · 1 Intervention: Rozibafusp Alfa · Intervention Types: Drug
Placebo for Rozibafusp Alfa
Drug
PlaceboComparator Group · 1 Intervention: Placebo for Rozibafusp Alfa · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 12, 24, 36, 44 and 52

Who is running the clinical trial?

AmgenLead Sponsor
1,292 Previous Clinical Trials
1,326,695 Total Patients Enrolled
12 Trials studying Lupus Erythematosus, Systemic
812 Patients Enrolled for Lupus Erythematosus, Systemic
MDStudy DirectorAmgen
835 Previous Clinical Trials
895,945 Total Patients Enrolled
12 Trials studying Lupus Erythematosus, Systemic
812 Patients Enrolled for Lupus Erythematosus, Systemic

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have provided informed consent prior to any study-specific activities/procedures.
Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2.
You are at least 18 years old and less than 75 years old at the time of screening.
You must have symptoms of pleurisy and pericarditis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Alabama100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Alabama at Birmingham100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%