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Protein Therapy
INBRX-101 vs Zemaira for Emphysema (ELEVAATE Trial)
Phase 2
Recruiting
Research Sponsored by Inhibrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of AATD
Evidence of emphysema secondary to AATD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights
ELEVAATE Trial Summary
This trial will compare two treatments for emphysema caused by AATD in adults.
Who is the study for?
Adults aged 18-80 with Alpha-1 Antitrypsin Deficiency (AATD) and emphysema can join this study. They must have a certain level of lung function and not be smokers. People with severe allergies, certain diabetes conditions, those on transplant lists or with recent infections, cancer history, heart failure or who've had similar treatments recently cannot participate.Check my eligibility
What is being tested?
The trial is testing INBRX-101 against Zemaira (a plasma-derived A1PI therapy) in adults with AATD-related emphysema to see which one works better for treating the condition.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to the drug components, immune system responses due to protein-based therapies like INBRX-101 or Zemaira, and other typical risks associated with intravenous medications.
ELEVAATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alpha-1 Antitrypsin Deficiency.
Select...
I have emphysema due to Alpha-1 Antitrypsin Deficiency.
Select...
I am between 18 and 80 years old.
ELEVAATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serum functional AAT (fAAT) levels at steady-state
Secondary outcome measures
Anti-drug antibodies
Covariate Analysis: Biometric Values: Age
Covariate Analysis: Biometric Values: Height
+7 moreSide effects data
From 2012 Phase 4 trial • 180 Patients • NCT0026183341%
Headache
32%
Nasopharyngitis
29%
Chronic obstructive pulmonary disease
24%
Oropharyngeal pain
23%
Cough
22%
Condition aggravated
19%
Lower respiratory tract infection
17%
Dyspnoea
16%
Upper respiratory tract infection
15%
Nausea
15%
Influenza
13%
Bronchitis
13%
Sinusitis
13%
Pyrexia
12%
Back pain
10%
Abdominal pain upper
9%
Pneumonia
9%
Fatigue
9%
Diarrhoea
9%
Urinary tract infection
8%
Rhinitis
8%
Muscle spasms
6%
Arthralgia
6%
Oedema peripheral
6%
Dizziness
6%
Gastritis
6%
Hypertension
5%
Pain in extremity
5%
Musculoskeletal pain
5%
Chest pain
5%
Toothache
5%
Gastrooesophageal reflux disease
5%
Vomiting
5%
Anxiety
4%
Influenza like illness
4%
Gastroenteritis
4%
Pharyngitis
2%
Abdominal discomfort
2%
Lung neoplasm
2%
Pneumothorax
1%
Gastroenteritis viral
1%
Respiratory failure
1%
Bladder cancer
1%
Pulmonary embolism
1%
Transurethral prostatectomy
1%
Angina pectoris
1%
Respiratory tract infection
1%
Tooth abscess
1%
Suicide attempt
1%
Abdominal pain
1%
Gastroesophageal reflux disease
1%
Ileus
1%
Post procedural haemorrhage
1%
Confusional state
1%
Hydronephrosis
1%
Hypotension
1%
Anaphylactic reaction
1%
Hyponatraemia
1%
Small intestinal obstruction
1%
Adhesion
1%
Diverticulitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Zemaira®
ELEVAATE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: INBRX-101 Q4WExperimental Treatment1 Intervention
IV every 4-weeks (Q4W) and placebo (normal saline)
Group II: INBRX-101 Q3WExperimental Treatment1 Intervention
IV every 3-weeks (Q3W) and placebo (normal saline)
Group III: Zemaira (A1PI)Active Control1 Intervention
60 mg/kg IV once weekly (QW) and placebo (normal saline)
Find a Location
Who is running the clinical trial?
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,657 Total Patients Enrolled
James KalabusStudy DirectorInhibrx, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on the waiting list for a lung or liver transplant.I have type 1 diabetes or my type 2 diabetes is not under control.My liver is severely damaged and not functioning properly.You have a severe deficiency in a type of antibody called Immunoglobulin A (IgA).I am allergic to INBRX-101, A1PI, or human IgG.I have received A1PI therapy within the last 5 weeks.I have been diagnosed with Alpha-1 Antitrypsin Deficiency.I have emphysema due to Alpha-1 Antitrypsin Deficiency.I am between 18 and 80 years old.I haven't had a lung infection or severe COPD symptoms in the last 4 weeks.I have not received IV immunoglobulins or biologic therapies in the last 30 days.I have cancer or had cancer within the last 5 years.I have a history of unstable heart-lung issues.I have serious heart failure symptoms.Your lung function test results show that your FEV1 is between 30% and 80% of what is expected for someone your age and size.You do not currently smoke.
Research Study Groups:
This trial has the following groups:- Group 1: INBRX-101 Q3W
- Group 2: INBRX-101 Q4W
- Group 3: Zemaira (A1PI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are those aged over 40 being sought to partcipate in this research?
"This medical trial is welcoming applicants over the age of 18 and younger than 80 years."
Answered by AI
Who is eligible to be involved in this trial?
"Aspiring participants should meet the criteria of alpha-1 antitrypsin deficiency and be aged between 18 to 80. Approximately 90 candidates will be admitted into this medical trial."
Answered by AI
Has the INBRX-101 Q3W drug undergone Federal Drug Administration scrutiny?
"Since INBRX-101 Q3W is in Phase 2 of clinical trials, there's evidence to back its safety but no solid data confirming efficacy. Therefore, our team assigned it a score of 2 on the 1 - 3 safety scale."
Answered by AI
How many participants are accepted in this experiment?
"Inhibrx, Inc. needs a total of 90 individuals who meet the study's criteria to successfully administer their trial at selected centres such as David Geffen School of Medicine and UC Davis Medical Center."
Answered by AI
How many sites are administering this research project?
"The David Geffen School of Medicine at UCLA in Los Angeles, UC Davis Medical Center in Sacramento, Colorado and National Jewish Medical and Research Center in Denver are among the 26 locations running this clinical trial."
Answered by AI
Are additional volunteers being sought for this experiment?
"As indicated on clinicaltrials.gov, this study is recruiting volunteers as of the present moment. The trial was initially published on May 1st 2023 and its listing has been modified for the latest time on May 9th of the same year."
Answered by AI
Who else is applying?
What site did they apply to?
Indiana University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I am hoping for a chance to breathe better.
PatientReceived 2+ prior treatments
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