Last updated: 10/07/2025 12:11:15

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in adults with Rifampicin susceptible Pulmonary Tuberculosis

GSK study ID
214912
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 administered as a two drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults with Rifampicin-susceptible Pulmonary Tuberculosis
Trial description: This study aims to measure the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics with GSK3036656 in combination with either delamanid or bedaquiline or BTZ-043, delamanid in combination with bedaquiline or standard of care for 14 days in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants will revert to the standard treatment (RIFAFOUR® e-275) once the study treatment (Day 1 to Day 14) has been completed.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in log10 CFU of Mycobacterium tuberculosis (MTB) (per milliliters of respiratory sputum samples)

Timeframe: Baseline and up to Day 14

Secondary outcomes:

Change from Baseline in time to sputum culture positivity

Timeframe: Baseline and up to Day 14

Number of participants with serious adverse events

Timeframe: Up to Day 28

Number of participants with adverse events of Grade 3 severity or higher

Timeframe: Up to Day 28

Number of participants with adverse events related to study drug

Timeframe: Up to Day 28

Number of participants withdrawn from the treatment due to adverse events

Timeframe: Up to Day 28

Number of participants withdrawn from the study due to adverse events

Timeframe: Up to Day 28

Number of participants with electrocardiogram (ECG) values of potential clinical importance (PCI)

Timeframe: Up to Day 28

Number of participants with hematology laboratory values of PCI

Timeframe: Up to Day 28

Number of participants with clinical chemistry laboratory values of PCI

Timeframe: Up to Day 28

Number of participants with vital signs of PCI

Timeframe: Up to Day 28

Interventions:
  • Drug: GSK3036656
  • Drug: Bedaquiline
  • Drug: Delamanid
  • Drug: RIFAFOUR e-275
  • Drug: BTZ-043
  • Enrollment:
    127
    Primary completion date:
    2025-27-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Tuberculosis
    Product
    GSK3036656
    Collaborators
    Click-TB Consortium
    Study date(s)
    July 2022 to May 2025
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Years
    Accepts healthy volunteers
    No
    • Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
    • Participants who have:
    • Evidence of a clinically significant (as judged by the Investigator) condition or abnormality (other than the indication being studied) that might compromise safety or the interpretation of trial efficacy or safety endpoints.
    • Clinically significant evidence of extrathoracic TB as judged by the Investigator.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bellville, South Africa, 7530
    Status
    Study Complete

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2025-27-05
    Actual study completion date
    2025-27-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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