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Double Blind: SPR720 Low Dose for Nontuberculous Mycobacterial Pulmonary Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Medical Facility, Northridge, CANontuberculous Mycobacterial Pulmonary DiseaseSPR720 1000 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Nontuberculous Mycobacterial Pulmonary Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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epetraborole + OBR

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Days 14 through Day 84 (FU)

Day 84
Clinical Response in the Clinically Evaluable (CE) Populations
Clinical Response in the micro-ITT Population
Day 84
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
Change From Baseline in Flu, COVID-19, or Other Illness Questionnaire (2 questions) for Quality of Life (QOL) Assessments
Change from Baseline in PROMIS® V1.0 Fatique Shortform 7a scale for Quality of Life (QOL) Assessments
Days 1 through 28
Slope of the Weekly Sputum Log10 CFU/mL Change From Days 1 Through 28 in micro-ITT Population
Day 1
Change from Baseline in the Sputum Log10 CFU/mL in the micro-ITT Population
Change from Baseline in the Sputum TTP Using MGIT in micro-ITT Population
Changes in Susceptibility in SPR719 From Days 1 through 56 (EOT) in the micro-ITT Population
Slope of the Time to Positivity (TTP) using MGIT on Samples of Induced Sputum From Days 1 Through 56 (EOT) in micro-ITT Population
Time to Negative Sputum Culture in micro-ITT Population
Day 1
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
Day 84
Percent with Negative Sputum Culture in micro-ITT Population
Day 84
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Day 1
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)
Maximum Plasma Concentration (Cmax) (Intensive PK group only)
Time to reach Cmax (Tmax) (Intensive PK group only)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Antiretroviral treatment
1
Gallium nitrate
2
epetraborole + OBR

Trial Design

4 Treatment Groups

Double Blind: SPR720 Low Dose
1 of 4
Double Blind: SPR720 High Dose
1 of 4
Open Label: SPR720 High Dose
1 of 4
Double Blind: Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

31 Total Participants · 4 Treatment Groups

Primary Treatment: Double Blind: SPR720 Low Dose · Has Placebo Group · Phase 2

Double Blind: SPR720 Low DoseExperimental Group · 2 Interventions: SPR720 500 mg, Placebo · Intervention Types: Drug, Drug
Double Blind: SPR720 High Dose
Drug
Experimental Group · 1 Intervention: SPR720 1000 mg · Intervention Types: Drug
Open Label: SPR720 High Dose
Drug
Experimental Group · 1 Intervention: SPR720 1000 mg · Intervention Types: Drug
Double Blind: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 14 through day 84 (fu)

Who is running the clinical trial?

Spero TherapeuticsLead Sponsor
17 Previous Clinical Trials
2,049 Total Patients Enrolled
Kamal Hamed, MDStudy DirectorSpero Therapeutics Inc
Angela Talley, MDStudy DirectorSpero Therapeutics Inc
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have never been treated for MAC before or you have been treated in the past, but now have symptoms of persistent, recurrent, or relapsed disease confirmed by recent culture evidence. You must have completed treatment successfully and have been off therapy for at least 3 months. Additionally, you must have shown signs of NTM-PD within the past six weeks and have a measured forced expiratory volume in 1 second (% predicted FEV1) of at least 30% on a recent pulmonary function test.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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