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Neutrophil Elastase Inhibitor

Alvelestat for Alpha-1 Antitrypsin Deficiency (ATALANTa Trial)

Phase 2
Waitlist Available
Led By Mark T Dransfield, MD
Research Sponsored by University of Alabama at Birmingham
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 16

Summary

This trial tests a pill called Alvelestat, which blocks a harmful enzyme in the lungs. It targets patients with Alpha-1 antitrypsin deficiency, who have low levels of a protective protein and suffer from lung damage. The goal is to see if the pill can reduce lung damage and slow down disease progression.

Eligible Conditions
  • Alpha-1 Antitrypsin Deficiency
  • Chronic obstructive pulmonary disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numbers and % of Subjects Who Experience at Least 1 Treatment-emergent Adverse Event
Within-individual % Change in Plasma Desmosine/Isodesmosine
Secondary study objectives
Blood Pharmacodynamic Markers of Neutrophil Activation and Elastase Activity. Change From Baseline in the Following Outcomes at End of the Treatment Within Patient and Compared to Placebo

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Alvelestat (MPH966)Active Control1 Intervention
Alvelestat (MPH966) 120mg (4 30mg tablets) twice daily by mouth for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
4 Placebo tablets twice daily by mouth for 12 weeks

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
378 Previous Clinical Trials
413,007 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,312 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,842 Previous Clinical Trials
8,173,087 Total Patients Enrolled
Mereo BioPharmaIndustry Sponsor
22 Previous Clinical Trials
1,622 Total Patients Enrolled
Mark T Dransfield, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Alvelestat (MPH966) (Neutrophil Elastase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03679598 — Phase 2
Alpha-1 Antitrypsin Deficiency Research Study Groups: Alvelestat (MPH966), Placebo
Alpha-1 Antitrypsin Deficiency Clinical Trial 2023: Alvelestat (MPH966) Highlights & Side Effects. Trial Name: NCT03679598 — Phase 2
Alvelestat (MPH966) (Neutrophil Elastase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03679598 — Phase 2
~9 spots leftby Dec 2025
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