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

Overview

About this study

The purpose of the study is to evaluate the microbiological response and clinical effectiveness of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). Additionally, to determine the safety and tolerability of SPR720 in a participants population with NTM- PD 3. Also, the pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Has a prior diagnosis of NTM-PD due to MAC.

2. Has at least one prior positive culture (sputum or bronchoalveolar lavage) for MAC in
the previous 6 months.

3. Has an induced sputum culture at screening positive for MAC by at least one of the
following methods performed by the microbiological laboratory: quantitative culture on
solid agar or growth on liquid media using Mycobacteria Growth Indicator Tubes (MGIT).

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 culture conversion;

2. Has recent culture evidence of persistent, recurrent, or relapsed disease; and

3. Has been off therapy for at least 3 months.

5. Has clinical signs and symptoms within the 6 weeks prior to consent that are
consistent with NTM-PD.

6. Has a measured forced expiratory volume in 1 second (% predicted forced expiratory
volume in 1 second [FEV1]) ≥30% on pulmonary function test within 3 months prior to
consent.

Exclusion Criteria:

1. In the opinion of the Investigator, is not a candidate for a 4-month delay in
initiation of standard multidrug therapy in order to participate in a placebo- controlled
linical trial or observation (e.g., severe symptoms, extensive disease burden).

2. Has disseminated or extrapulmonary NTM.

3. Has end-stage NTM-PD or treatment-refractory NTM-PD.

4. Has isolation on sputum cultures of any species of Mycobacterium other than a species
included in MAC within the past 6 months.

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.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sarah Chalmers, M.D.

Closed for enrollment

Contact information:

Kayla Quinn

5075380595

quinn.kayla2@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20543856

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