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Protein Therapy

INBRX-101 vs Zemaira for Emphysema (ELEVAATE Trial)

Phase 2
Recruiting
Research Sponsored by Inhibrx Biosciences, 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
Must not have
On waiting list for lung or liver transplant
Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Alpha-1 Antitrypsin Deficiency.
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I have emphysema due to Alpha-1 Antitrypsin Deficiency.
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on the waiting list for a lung or liver transplant.
Select...
I have type 1 diabetes or my type 2 diabetes is not under control.
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My liver is severely damaged and not functioning properly.
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I am allergic to INBRX-101, A1PI, or human IgG.
Select...
I haven't had a lung infection or severe COPD symptoms in the last 4 weeks.
Select...
I have cancer or had cancer within the last 5 years.
Select...
I have a history of unstable heart-lung issues.
Select...
I have serious heart failure symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum functional AAT (fAAT) levels at steady-state
Secondary study objectives
Anti-drug antibodies
Covariate Analysis: Biometric Values: Age
Covariate Analysis: Biometric Values: Height
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 Biosciences, IncLead Sponsor
6 Previous Clinical Trials
983 Total Patients Enrolled
SanofiLead Sponsor
2,209 Previous Clinical Trials
4,039,676 Total Patients Enrolled
Inhibrx, Inc.Lead Sponsor
8 Previous Clinical Trials
1,517 Total Patients Enrolled

Media Library

INBRX-101 (Protein Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05856331 — Phase 2
Alpha-1 Antitrypsin Deficiency Research Study Groups: INBRX-101 Q3W, INBRX-101 Q4W, Zemaira (A1PI)
Alpha-1 Antitrypsin Deficiency Clinical Trial 2023: INBRX-101 Highlights & Side Effects. Trial Name: NCT05856331 — Phase 2
INBRX-101 (Protein Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856331 — Phase 2
~28 spots leftby Jun 2025
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