A Phase 2 interventional study of Placebo and SPR720 500 mg in Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), sponsored by Spero Therapeutics. Completed at 28 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by Spero Therapeutics · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate
66 studies on the registry are indexed under Mycobacterium avium-intracellulare Infection; 8 are open to participants now.
This study's enrollment of 25 is below the median of 95 across 44 interventional studies indexed under Mycobacterium avium-intracellulare Infection.
Browse Mycobacterium avium-intracellulare Infection studies →Spero Therapeutics is the lead sponsor of 22 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 3 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC and meets all of the following criteria:
Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD with ≥2 of the following:
Exclusion Criteria:
Prior exposure to SPR720. Participants who are unable to comply with the requirements of the study or who in the opinion of the Investigator should not participate in the study are not eligible
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days.
Drug: Placebo
Participants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days.
Drug: SPR720 500 mg
Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
Drug: SPR720 1000 mg
Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
Drug: SPR720 1000 mg
Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days.
Drug: SPR720 500 mg
Placebo-matching capsules was administered orally.
SPR720 500 mg (250 mg × 2 capsules) was administered orally.
SPR720 500 mg (250 mg × 4 capsules) was administered orally.
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
Time frame: Days 1 through 56 (end of the treatment [EOT])
Slope of the Weekly Sputum Log10 CFU/mL Change From Days 1 Through 28 in micro-ITT Population
Time frame: Days 1 through 28
Slope of the Time to Positivity (TTP) using Mycobacteria Growth Indicator Tube (MGIT) on Samples of Induced Sputum From Days 1 Through 56 (EOT) in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Change from Baseline in the Sputum Log10 CFU/mL in the micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Change from Baseline in the Sputum TTP Using MGIT in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Time to Negative Sputum Culture in micro-ITT Population
Time frame: Days 1 through 56 (EOT)
Percent with Negative Sputum Culture in micro-ITT Population
Time frame: Days 14 through Day 84 (FU)
Changes in Susceptibility in SPR719 From Days 1 through 56 (EOT) in the micro-ITT Population
Susceptibility is ≥4-fold increase in minimum inhibitory concentration for same pathogen identified at Baseline.
Time frame: Days 1 through 56 (EOT)
Clinical Response in the micro-ITT Population
Investigator indicated their assessment of participants overall clinical response as resolved, improved, unchanged, or worsened.
Time frame: Baseline up to Day 84 (FU)
Clinical Response in the Clinically Evaluable (CE) Populations
Investigator indicated their assessment of participants overall clinical response as resolved, improved, unchanged, or worsened.
Time frame: Baseline up to Day 84 (FU)
Change From Baseline in 11-point Nontuberculous Mycobacteria Pulmonary Disease (NTM-PD) Symptoms and Impact Scale for Quality of Life (QOL) Assessments
The 11-point NTM-PD Symptoms and Impact Scale will evaluate specific clinical signs and symptoms and QOL improvements and will include symptoms of chronic cough, fatigue, frequent throat clearing, dyspnea, hemoptysis, excessive mucus (sputum) production, chills, night sweats, loss of appetite, unintended weight loss, wheezing, and chest pain.
Time frame: Baseline up to FU Day 84
Change From Baseline in 6-point Patient Global Impression of Severity (PGI-S) Scale for Quality of Life (QOL) Assessments
The PGI-S scale is comprised of a 6-point verbal descriptor scale to determine meaningful change reported for the other symptom ratings in participants with NTM-PD.
Time frame: Baseline up to FU Day 84
Change From Baseline in 7-point Patient Global Impression of Change (PGI-C) scale for Quality of Life (QOL) Assessments
The PGI-C scale is a patient-reported rating of improvement on a 7-point verbal descriptor scale.
Time frame: Baseline up to FU Day 84
Change From Baseline in Flu, COVID-19, or Other Illness Questionnaire (2 questions) for Quality of Life (QOL) Assessments
This 2-question form will assess the participants flu, COVID-19 or other illness status and how these illnesses have affected the participants NTM-PD disease over the past 7 days.
Time frame: Baseline up to FU Day 84
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS®) V1.0 Fatigue Short form 7a scale for Quality of Life (QOL) Assessments
The PROMIS® scale will assess the participants experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities using a validated 5-point Likert scale.
Time frame: Baseline up to FU Day 84
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether related to this product or not.
Time frame: From first dose of study drug (Day 1) up to follow up Day 84
Maximum Plasma Concentration (Cmax) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Time to reach Cmax (Tmax) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Area Under the Concentration-time Curve (AUC0-τ) (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 Cmax on Day 14 Compared to Day 1 (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Accumulation Ratio of SPR719 AUC0-τ on Day 14 Compared to Day 1 (Intensive PK group only)
Time frame: Pre-dose and post-dose on Days 1 and 14
Plan to share: No
Ran from Dec 2022 to primary completion in Oct 2024, 21 months.
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Mycobacterium avium-intracellulare Infection →