Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TBPhase 2NCT03563599
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
A Phase 2 study testing Telacebec (Q203) and Rifafour e-275 in people with Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB, run by Qurient Co., Ltd. at 2 sites in South Africa.
Trial summary
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
- What is being tested?
- Telacebec (Q203) and Rifafour e-275
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 23 Jul 2018to 9 Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
- A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
- Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
- Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
- Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol
Who cannot join
- The patient is mentally or legally incapacitated at Screening
- Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
- Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
- The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
- The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
TASK Applied Science
Cape Town
UCT Lung Institute
Cape Town
About this study
Official title: An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients With Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Being tested
- Telacebec (Q203), Rifafour e-275
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telacebec (Q203)Drug
High, Mid, Low dose of telacebec
Rifafour e-275Drug
RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)
| Study group | Role | What they receive |
|---|---|---|
| Telacebec (Q203) tablet | Experimental | Not described Receives: Drug: Telacebec (Q203) |
| Rifafour e-275 | Active comparator | Not described Receives: Drug: Rifafour e-275 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The EBA (early bactericidal activity) of telacebec (Q203)
The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14
Measured: Days 0 to 14 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start23 Jul 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qurient Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563599
- Sponsor's protocol ID
- Q203-TB-P2-ZA001
- Status last verified
- Sep 2019
- First submitted
- 9 Jun 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Janssen S, Upton C, de Jager VR, van Niekerk C, Dawson R, Hutchings J, Kim J, Choi J, Nam K, Sun E, Diacon AH. Telacebec, a Potent Agent in the Fight against Tuberculosis: Findings from a Randomized, Phase 2 Clinical Trial and Beyond. Am J Respir Crit Care Med. 2025 Aug;211(8):1504-1512. doi: 10.1164/rccm.202408-1632OC.
PubMed 40116781
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients With Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT03563599
- Acronym / sponsor ID
- Q203-TB-P2-ZA001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Qurient Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telacebec (Q203) tablet | Experimental | Drug: Telacebec (Q203) |
| Rifafour e-275 | Active comparator | Drug: Rifafour e-275 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A new episode of pulmonary TB determined by testing at the study appointed laboratory: Mycobacterium tuberculosis positive and rifampicin and isoniazid sensitive on a rapid molecular test
- A chest X-ray taken no more than 14 days before Screening which in the opinion of the Investigator is consistent with TB
- Sputum smear positive on direct microscopy for acid-fast bacilli on at least 1 pre-treatment sputum sample
- Ability to produce an adequate volume of sputum as determined by an approximately 16-hour overnight sample collection
- Be of non-childbearing potential or using effective methods of birth control, as defined in the protocol
Key exclusion criteria (5 listed)
- The patient is mentally or legally incapacitated at Screening
- Any condition or circumstance, in the opinion of the Investigator, which may make the patient unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the patient's safety
- Clinically significant evidence of extra-thoracic TB (miliary TB, abdominal TB, urogenital TB, osteoarthritic TB, TB meningitis), as judged by the Investigator
- The patient has been infected with hepatitis B or C virus as confirmed by tests for hepatitis B core antibodies, hepatitis B surface antigens, and the hepatitis C virus antibodies
- The patient with history of allergic reaction to isoniazid, rifampicin, pyrazinamide, ethambutol or related substances (eg, tosylate), as confirmed by the clinical judgement of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telacebec (Q203)High, Mid, Low dose of telacebec | Drug | Telacebec (Q203) tablet |
| Rifafour e-275RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol) | Drug | Rifafour e-275 |
Primary outcome
The EBA (early bactericidal activity) of telacebec (Q203)
Time frame: Days 0 to 14 post dose
The EBA determined by the rate of change in the time to positivity (TTP) in sputum over the periods Days 0 to 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Derived from this study: PubMed 40116781Janssen S, Upton C, de Jager VR, van Niekerk C, Dawson R, Hutchings J, Kim J, Choi J, Nam K, Sun E, Diacon AH. Telacebec, a Potent Agent in the Fight against Tuberculosis: Findings from a Randomized, Phase 2 Clinical Trial and Beyond. Am J Respir Crit Care Med. 2025 Aug;211(8):1504-1512. doi: 10.1164/rccm.202408-1632OC.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telacebec (Q203) and Rifafour e-275 in people with Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB, run by Qurient Co., Ltd. at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The EBA (early bactericidal activity) of telacebec (Q203) (time frame: Days 0 to 14 post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.