A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
NCT ID: NCT05496374
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2022-12-14
2024-12-02
Brief Summary
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1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD).
2. The safety and tolerability of SPR720 in participants with NTM- PD
3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Investigator Blind: Placebo
Participants received SPR720 matching-placebo capsules, orally, once daily (QD) for 56 days.
Placebo
Placebo-matching capsules was administered orally.
Investigator Blind: SPR720 500 mg
Participants received SPR720 500 mg (250 mg × 2) capsules along with 2 SPR720 matching- placebo capsules, orally, QD for 56 days.
SPR720 500 mg
SPR720 500 mg (250 mg × 2 capsules) was administered orally.
Investigator Blind: SPR720 1000 mg
Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
SPR720 1000 mg
SPR720 500 mg (250 mg × 4 capsules) was administered orally.
Open-label: SPR720 1000 mg
Participants received SPR720 1000 mg (250 mg × 4) capsules, orally, QD for 56 days.
SPR720 1000 mg
SPR720 500 mg (250 mg × 4 capsules) was administered orally.
Open-label: SPR720 500 mg
Participants received SPR720 500 mg (250 mg × 2) capsules, orally, twice daily (BID) for 56 days.
SPR720 500 mg
SPR720 500 mg (250 mg × 2 capsules) was administered orally.
Interventions
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Placebo
Placebo-matching capsules was administered orally.
SPR720 500 mg
SPR720 500 mg (250 mg × 2 capsules) was administered orally.
SPR720 1000 mg
SPR720 500 mg (250 mg × 4 capsules) was administered orally.
Eligibility Criteria
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Inclusion Criteria
2. Has at least one prior lower respiratory culture (sputum or bronchoalveolar lavage \[BAL\]) positive for MAC in the 12 months prior to consent
3. Has an induced sputum culture at Screening positive for MAC by quantitative culture on solid agar
4. 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:
1. Has a history of successful treatment with sputum culture conversion to negative
2. Has recent sputum or BAL culture evidence of recurrent or relapsed disease and
3. Has been off therapy for at least 3 months prior to consent
5. Has clinical signs and symptoms within the 6 weeks prior to consent that are consistent with NTM-PD with ≥2 of the following:
1. chronic cough
2. fatigue
3. frequent throat clearing
4. shortness of breath (dyspnea)
5. coughing up of blood (hemoptysis)
6. excessive mucus (sputum) production
7. fever (temperature \>38ºC or \>100.4ºF)
8. night sweats
9. loss of appetite
10. unintended weight loss
11. wheezing
12. chest pain
6. Has a measured forced expiratory volume in the first second following maximal inhalation (FEV1) % predicted ≥30% within 3 months prior to consent. If prior FEV1% predicted test result is not available, obtain FEV1% predicted at Screening to confirm eligibility
Exclusion Criteria
2. Has disseminated or extrapulmonary NTM disease
3. Has end-stage NTM-PD or treatment-refractory NTM-PD
4. Has isolation on lower respiratory (sputum or BAL) cultures of any Mycobacterium species other than those included in MAC within the 6 months prior to consent
5. Has any other condition or prior therapy, which, in the opinion of the Investigator, would make the participant unsuitable for this study, including compliance with all study assessments and adherence to the protocol schedule of assessment
6. 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
18 Years
ALL
No
Sponsors
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Spero Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Xilla Ussrey, MD
Role: STUDY_DIRECTOR
Spero Therapeutics Inc
Locations
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Medical Facility
Birmingham, Alabama, United States
Medical Facility
Fresno, California, United States
Medical Facility
Los Angeles, California, United States
Medical Facility
Newport Beach, California, United States
Medical Facility
Northridge, California, United States
Medical Facility
Santa Clarita, California, United States
Medical Facility
Washington D.C., District of Columbia, United States
Medical Facility
Kissimmee, Florida, United States
Medical Facility
Loxahatchee Groves, Florida, United States
Medical Facility
Miami, Florida, United States
Medical Facility
Sebring, Florida, United States
Medical Facility
Tampa, Florida, United States
Medical facility
Atlanta, Georgia, United States
Medical Facility
Iowa City, Iowa, United States
Medical Facility
Kansas City, Kansas, United States
Medical Facility
New Bedford, Massachusetts, United States
Medical Facility
Rochester, Minnesota, United States
Medical Facility
Lebanon, New Hampshire, United States
Medical Facility
New Hyde Park, New York, United States
Medical Facility
Chapel Hill, North Carolina, United States
Medical Facility
Winston-Salem, North Carolina, United States
Medical Facility
Cleveland, Ohio, United States
Medical Facility
Portland, Oregon, United States
Medical Facility
Pittsburgh, Pennsylvania, United States
Medical Facility
Charleston, South Carolina, United States
Medical Facility
Denison, Texas, United States
Medical Facility
Sherman, Texas, United States
Medical Facility
Tyler, Texas, United States
Countries
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Other Identifiers
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SPR720-202
Identifier Type: -
Identifier Source: org_study_id