Last updated: 05/21/2026 06:31:04

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
Completed
Completed
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 measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and 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 reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from baseline in log10 colony forming units (CFU) of mycobacterium tuberculosis (MTB)

Timeframe: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14

Secondary outcomes:

Change from baseline in time to sputum culture positivity

Timeframe: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14

Number of participants with serious adverse events (SAEs)

Timeframe: From Day 1 to Day 28

Number of participants with adverse events (AE) of Grade 3 severity or higher

Timeframe: From Day 1 to Day 28

Number of participants with adverse events related to study treatment

Timeframe: From Day 1 to Day 28

Number of participants withdrawn from the treatment due to adverse events

Timeframe: From Day 1 to Day 28

Number of participants withdrawn from the study due to adverse events

Timeframe: From Day 1 to Day 28

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

Timeframe: From Day 1 to Day 28

Number of participants with hematology laboratory values of PCI

Timeframe: From Day 1 to Day 28

Number of participants with clinical chemistry laboratory values of PCI

Timeframe: From Day 1 to Day 28

Number of participants with vital signs of PCI

Timeframe: From Day 1 to Day 28

Interventions:
Drug: GSK3036656
Drug: Bedaquiline
Drug: Delamanid
Drug: RIFAFOUR e-275
Drug: BTZ-043
Drug: Pretomanid
Drug: Linezolid
Drug: Moxifloxacin
Enrollment:
127
Observational study model:
Not applicable
Primary completion date:
2025-27-05
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 were 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Participants had:
  • There was evidence of a clinically significant condition or abnormality (as judged by the Investigator) (other than the indication being studied) that might have compromised safety or the interpretation of trial efficacy or safety endpoints.
  • There was 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, Unmapped, 7530
Status
Study Complete

Study documents

Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2025-27-05
Actual study completion date
2025-27-05

Plain language summaries

Summary of results in plain language
Available language(s): English, Afrikaans, Xhosa

To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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