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Antibiotic
Open-label: SPR720 1000 mg for Nontuberculous Mycobacterial Pulmonary Disease
Phase 2
Recruiting
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 days 14 through day 84 (fu)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 14 through day 84 (fu)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 14 through day 84 (fu)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Slope of the Weekly Sputum Log10 Colony Forming Units Per Millilitre (CFU/mL) Change From Day 1 Through 56 in micro-Intent to Treat (m-ITT) Population
Secondary outcome measures
Accumulation Ratio of SPR719 AUC0-τ on Day 14 Compared to Day 1 (Intensive PK group only)
Accumulation Ratio of SPR719 Cmax on Day 14 Compared to Day 1 (Intensive PK group only)
Area Under the Concentration-time Curve (AUC0-τ) (Intensive PK group only)
+17 moreTrial 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.
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Who is running the clinical trial?
Spero TherapeuticsLead Sponsor
22 Previous Clinical Trials
4,801 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung disease caused by NTM is in its final stage or hasn't responded to treatments.I have been diagnosed with NTM lung disease caused by MAC.I have never been treated for MAC, or I meet all criteria if previously treated.My NTM infection has spread beyond my lungs.My lung function test shows I can breathe out at least 30% of air in one second.I have shown signs of NTM lung disease in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Open-label: SPR720 1000 mg
- Group 2: Double Blind: SPR720 500 mg
- Group 3: Double Blind: Placebo
- Group 4: Double Blind: SPR720 1000 mg
- Group 5: Open Label: SPR720 500 mg
Awards:
This trial has 0 awards, including: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.
Has the FDA authorized Open Label: SPR720 High Dose for public use?
"Open Label: SPR720 High Dose has been assigned a safety score of 2, as it is currently undergoing Phase 2 trials and there are data points indicating that the drug may be safe but no evidence yet suggesting efficacy."
Answered by AI
Are there any positions available for participants in this research project?
"Affirmative. According to clinicaltrials.gov, this biomedical research is still open for recruitment and was initially published on December 1st 2022 before being edited at the start of July 2021. A total of 31 participants are sought in 3 distinct areas."
Answered by AI
How many participants are currently enrolled in this experiment?
"Affirmative. According to the information hosted at clinicaltrials.gov, this medical study is actively searching for participants, having been initially published on December 1st 2022 and recently revised as of July 12th 2022. The trial requires 31 patients from 3 distinct sites."
Answered by AI
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