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Trial record 2 of 2 for:    SPR720

Phase 2a Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553406
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Spero Therapeutics

Brief Summary:
To evaluate the pharmacokinetics (PK) of SPR719 generated from the orally (po) administered SPR720 prodrug in a patient population with nontuberculous mycobacteria pulmonary disease (NTM-PD)

Condition or disease Intervention/treatment Phase
Mycobacterium Avium Complex Drug: SPR720 Drug: Placebo Drug: Open-label SOC Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment Arms 1 to 3 are masked while Treatment Arm 4 is open-label
Primary Purpose: Treatment
Official Title: A Randomized, Partially Blinded, Placebo- and Comparator-Controlled, Multicenter, Phase 2a, Dose Ranging, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
Estimated Study Start Date : November 11, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SPR720 low dose
SPR720 500 mg (2 capsules of 250 mg SPR720 and 2 capsules of placebo) administered orally once daily for 28 days
Drug: SPR720
250 mg capsules

Experimental: SPR720 high dose
SPR720 1000 mg (4 capsules of 250 mg SPR720) administered orally once daily for 28 days
Drug: SPR720
250 mg capsules

Placebo Comparator: Placebo
4 capsules of placebo once daily for 28 days
Drug: Placebo
4 capsules of matching placebo

Active Comparator: Standard of Care (SOC)

Clarithromycin 500-1000 mg plus ethambutol HCl 15 mg/kg po once daily or Azithromycin 250-500 mg plus ethambutol HCl 15 mg/k po once daily. Optional rifampin 600 mg or rifabutin 300 mg po once daily may be added to the SOC regimen for up to 28 days.

Additional SOC treatments may be considered in consultation with the medical monitor.

Drug: Open-label SOC

Clarithromycin 500-1000 mg plus ethambutol HCl 15 mg/kg po once daily or Azithromycin 250-500 mg plus ethambutol HCl 15 mg/k po once daily. Optional rifampin 600 mg or rifabutin 300 mg po once daily may be added to the SOC regimen for up to 28 days.

Additional SOC treatments may be considered in consultation with the medical monitor.





Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: From Day 1 to Day 28 ]
    For Treatment Arms 1, 2, and 3

  2. Time to reach Cmax (Tmax) [ Time Frame: From Day 1 to Day 28 ]
    For Treatment Arms 1, 2, and 3

  3. Area under the concentration-time curve from zero to tau, where tau is the dosing interval (AUC0-tau), [ Time Frame: From Day 1 to Day 28 ]
    For Treatment Arms 1, 2, and 3

  4. Accumulation ratio of SPR719 [ Time Frame: From Day 1 to Day 28 ]
    For Treatment Arms 1, 2, and 3


Secondary Outcome Measures :
  1. Reported adverse events (AEs) [ Time Frame: Day 1 to Day 56 ]
  2. Clinically meaningful change in physical examination findings [ Time Frame: Day 1 to Day 56 ]
    To assess the incidents of abnormal body system assessments following 28 days of IP administration

  3. Concomitant medication usage [ Time Frame: Day 1 to Day 56 ]
    The type and frequency of medications used

  4. Changes from baseline in laboratory tests [ Time Frame: Day 1 to Day 56 ]
    To assess the incidents of abnormal hematology, biochemistry, coagulation and urinalysis assessments following 28 days of IP administration

  5. Clinically significant (CS) out-of-normal range laboratory tests [ Time Frame: Day 1 to Day 56 ]
    To assess the incidents of clinically significant abnormal hematology, biochemistry, coagulation and urinalysis assessments following 28 days of IP administration

  6. Shifts from baseline in selected laboratory tests using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 shift categories [ Time Frame: Day 1 to Day 56 ]
  7. Changes from baseline in vital sign measurements [ Time Frame: Day 1 to Day 56 ]
    To assess the incidents of abnormal heart rate, blood pressure and body temperature assessments following 28 days of IP administration

  8. 12-lead ECGs [ Time Frame: Day 1 to Day 56 ]
    To assess the incidents of abnormal heart rate, cardiac rhythm, PR interval, RR interval, QRS interval, QT interval and QTC interval assessments following 28 days of IP administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis of NTM-PD due to MAC
  • Had at least 1 prior positive culture (sputum or bronchoalveolar lavage) positive for MAC in the previous 6 months
  • Has an induced sputum culture at screening positive for MAC by at least one of the following methods performed by the microbiology laboratory: quantitative culture on solid agar or growth on liquid media (MGIT)
  • Is either treatment naïve and has not received any prior treatment for MAC, OR if previously treated for MAC, has culture evidence of persistent, recurrent, or relapsed disease and has been off therapy for at least 6 months
  • In the opinion of the Investigator, is ready to initiate treatment (treatment naïve) or reinitiate treatment (previously treated) within the next 3 months, and for whom a delay, in order to participate in a placebo-controlled clinical trial, is considered reasonable and clinically acceptable
  • Had clinical signs and symptoms within the 6 weeks before the date of consent that are consistent with NTM-PD with at least two 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
    8. night sweats
    9. loss of appetite
    10. unintended weight loss
    11. wheezing
    12. chest pain
  • Has a measured forced expiratory volume in 1 second (% predicted FEV1) ≥30% on pulmonary function test within 3 months prior to consent
  • Has a chest radiograph (CXR) or computed tomography (CT) scan within 6 months prior to consent with findings consistent with NTM-PD. If no CXR or CT scan is available, a CXR or CT scan should be performed at screening to confirm eligibility.
  • Other inclusion criteria per protocol

Exclusion Criteria:

  • Has disseminated or extrapulmonary NTM
  • Has end-stage NTM-PD or treatment-refractory NTM-PD and is unlikely to respond to protocol-specified SOC treatment
  • Had isolation on sputum cultures of any species of Mycobacterium other than a species included in MAC within the past 6 months
  • Had prior isolation of MAC with macrolide resistance
  • Has received any systemic (oral or IV) or inhaled antibiotic with activity against MAC between consent and randomization
  • Has a potentially confounding underlying pulmonary disease, including but not limited to cystic fibrosis, active pulmonary malignancy (primary or metastatic), NTM-hypersensitivity disease pneumoconiosis, or another advanced lung disease with a % predicted FEV1<30%
  • Other exclusion criteria per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553406


Contacts
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Contact: Caroline Wass 8572421586 cwass@sperotherapeutics.com

Locations
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United States, Florida
Medical Facility Recruiting
Atlantis, Florida, United States, 33462
Medical Facility Recruiting
Clearwater, Florida, United States, 33765
Medical Facility Recruiting
Kissimmee, Florida, United States, 34746
Medical Facility Recruiting
West Palm Beach, Florida, United States, 33407
United States, North Carolina
Medical Facility Recruiting
Charlotte, North Carolina, United States, 28207
Medical Facility Recruiting
Mooresville, North Carolina, United States, 28117
Medical Facility Recruiting
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Spero Therapeutics
Investigators
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Study Director: David Melnick, MD Spero Therapeutics, Inc.
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Responsible Party: Spero Therapeutics
ClinicalTrials.gov Identifier: NCT04553406    
Other Study ID Numbers: SPR720-201
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous