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Antibiotic

SPR720 for MAC Lung Disease

Phase 2
Waitlist Available
Research Sponsored by Spero Therapeutics
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 from first dose of study drug (day 1) up to follow up day 84

Summary

This trial looks at how a new drug treats non-TB lung disease and its side effects.

Who is the study for?
This trial is for people with a lung condition caused by Mycobacterium Avium Complex (MAC). It's open to those who haven't been treated yet, or have had successful treatment but the disease came back and they've been off therapy for at least 3 months. Participants need to be able to breathe out a certain amount of air in one second and show recent signs of MAC.
What is being tested?
The study tests SPR720 against a placebo in treating MAC pulmonary disease. Patients will take either 500 mg or 1000 mg doses of SPR720 orally, or a placebo, to see how well it works, its safety, tolerability, and how the body processes it.
What are the potential side effects?
While specific side effects are not listed here, generally participants may experience reactions related to medication tolerance issues such as gastrointestinal discomforts, potential allergic reactions or other drug-related adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug (day 1) up to follow up day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug (day 1) up to follow up day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change From Baseline in 11-point Nontuberculous Mycobacteria Pulmonary Disease (NTM-PD) Symptoms and Impact Scale for Quality of Life (QOL) Assessments
Change From Baseline in 6-point Patient Global Impression of Severity (PGI-S) Scale for Quality of Life (QOL) Assessments
Change From Baseline in 7-point Patient Global Impression of Change (PGI-C) scale for Quality of Life (QOL) Assessments
+6 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-label: SPR720 1000 mgExperimental Treatment1 Intervention
Participants will receive SPR720 1000 mg \[250 mg × 4 capsules\], orally QD for 56 days.
Group II: Open Label: SPR720 500 mgExperimental Treatment1 Intervention
Participants will receive SPR720 500 mg \[250 mg × 2 capsules\], orally twice daily (BID) for 56 days.
Group III: Double Blind: SPR720 500 mgExperimental Treatment1 Intervention
Participants will receive SPR720 500 milligrams (mg) \[250 mg × 2 capsules and 2 matching placebo capsules, orally QD for 56 days.
Group IV: Double Blind: SPR720 1000 mgExperimental Treatment1 Intervention
Participants will receive SPR720 1000 mg \[250 mg × 4 capsules\], orally QD for 56 days.
Group V: Double Blind: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo 4 capsules, orally once daily (QD) for 56 days.

Find a Location

Who is running the clinical trial?

Spero TherapeuticsLead Sponsor
23 Previous Clinical Trials
4,847 Total Patients Enrolled
Angela Talley, MDStudy DirectorSpero Therapeutics Inc
1 Previous Clinical Trials
36 Total Patients Enrolled
Kamal Hamed, MDStudy DirectorSpero Therapeutics Inc
1 Previous Clinical Trials
2,648 Total Patients Enrolled

Media Library

SPR720 (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05496374 — Phase 2
Nontuberculous Mycobacterial Pulmonary Disease Research Study Groups: Open-label: SPR720 1000 mg, Double Blind: SPR720 500 mg, Double Blind: Placebo, Double Blind: SPR720 1000 mg, Open Label: SPR720 500 mg
Nontuberculous Mycobacterial Pulmonary Disease Clinical Trial 2023: SPR720 Highlights & Side Effects. Trial Name: NCT05496374 — Phase 2
SPR720 (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05496374 — Phase 2
~12 spots leftby Dec 2025
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