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Cytokine

Efavaleukin 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 baseline, week 8, 12, 24, 36, and 52
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is effective and safe for people with Lupus.

Eligible Conditions
  • Systemic Lupus Erythematosus (SLE)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8, 12, 24, 36, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, 12, 24, 36, 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 Participants Achieving a Systemic Lupus Erythematosus Responder Index-4 (SRI-4) Response at Week 52
Secondary outcome measures
Change from Baseline in Lupus Quality of Life (QoL) Questionnaire Score
Change from Baseline in Medical Outcomes Short Form-36 Questionnaire Score
Change from Baseline in Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a Instrument (PROMIS Fatigue SF 7A) Fatigue Score
+11 more

Side effects data

From 2021 Phase 1 trial • 35 Patients • NCT03451422
60%
Injection site erythema
40%
Dry mouth
40%
Asthenia
40%
Erythema
40%
Fatigue
40%
Injection site reaction
40%
Non-cardiac chest pain
20%
Blood pressure decreased
20%
Upper respiratory tract infection
20%
Vomiting
20%
Decreased appetite
20%
Body temperature increased
20%
Dysphagia
20%
Injection site pruritus
20%
Spinal pain
20%
Depression
20%
Dry skin
20%
Rash
20%
Injection site warmth
20%
Skin papilloma
20%
Hypertension
20%
Psychomotor hyperactivity
20%
Bowel movement irregularity
20%
Dyspepsia
20%
Nausea
20%
Reflux gastritis
20%
Injection site inflammation
20%
Injection site mass
20%
Injection site rash
20%
Back pain
20%
Musculoskeletal chest pain
20%
Dizziness
20%
Presyncope
20%
Sciatica
20%
Sleep disorder
20%
Pollakiuria
20%
Oropharyngeal pain
20%
Petechiae
100%
80%
60%
40%
20%
0%
Study treatment Arm
AMG 592 Cohort 1
AMG 592 Cohort 2
AMG 592 Cohort 3
Placebo
AMG 592 Cohort 4
AMG 592 Cohort 5

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Efavaleukin Alfa Dose Level Two + Standard of CareExperimental Treatment2 Interventions
Group II: Efavaleukin Alfa Dose Level Three + Standard of CareExperimental Treatment2 Interventions
Group III: Efavaleukin Alfa Dose Level One + Standard of CareExperimental Treatment2 Interventions
Group IV: Placebo + Standard of CarePlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efavaleukin Alfa
2018
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,520 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
923,963 Total Patients Enrolled

Frequently Asked Questions

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

Has this clinical trial broken new ground in its field?

"As of now, two independent trials for Efavaleukin Alfa are running in 28 different countries and 126 cities. The initial trial was sponsored by Amgen and began in 2021; it included 320 patients who successfully completed Phase 2 approval. Since then, a total of 18,542 studies have been finished."

Answered by AI

Has Efavaleukin Alfa received authorization from the FDA?

"Based on the available data, our team at Power rated efavaleukin alfa's safety as a 2. This is because there have been some studies that support its safety but none demonstrating efficacy."

Answered by AI

What is the scope of enrollment for this clinical research initiative?

"This clinical trial demands 320 suitable participants. Those interested in participating can find locations such as the New york University Grossman School of Medicine, Brooklyn and Western Kentucky Rheumatology PLLC, Hopkinsville to join the research study."

Answered by AI

Are there any openings for participants in this experiment?

"As specified on clinicaltrials.gov, this trial is actively seeking participants with recruitment beginning on May 6th 2021 and the most recent update occurring October 19th 2022."

Answered by AI

Is it feasible for me to enroll in this clinical experiment?

"This clinical trial has recruited 320 patients who suffer from Libman-Sacks Disease, with ages ranging between 18 and 75. The criteria for eligible participants are as follows: a hybrid SLEDAI score ≥ 6 points & a Clinical hSLEDAI score of at least 4; prednisone/OCS dose ≤ 20 mg/day with stability at baseline visit & two weeks prior to screening; SLE treatments (hydroxychloroquine, chloroquine etc.) must have been stable since the screening visit; active disease indicated by clinical hSLEDAI ≥4 without laboratory results inclusion; BILAG index scores show 1 A"

Answered by AI

How many healthcare centers are currently implementing this research trial?

"This medical trial is hosted by New york University Grossman School of Medicine in Brooklyn, Western Kentucky Rheumatology PLLC in Hopkinsville and Toronto Western Hospital in Ontario. Moreover, there are 50 other sites offering this study to patients across the world."

Answered by AI

Can you provide information about prior research efforts involving Efavaleukin Alfa?

"Currently, two studies are underway on the effectiveness of Efavaleukin Alfa. Neither trial is at phase 3 yet; however, there are 299 different sites hosting these trials in such areas as Sankt Gallen and Texas."

Answered by AI

Does this investigation accept volunteers who are octogenarians?

"Based on the trial's requirements, only those aged 18-75 are qualified to take part in this medical research."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
2021. "Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04680637.
~43 spots leftby Apr 2025
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