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Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB

18. august 2026 oppdatert av: Global Alliance for TB Drug Development

A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis

The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200/100SPaL-4/13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.

Participants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :

  1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or
  2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.

The primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure/relapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a phase 2, randomised, multi-center, partially blinded, clinical trial conducted in 2 treatment arms.

The trial will be performed at multiple centers in South Africa and Tanzania in at approximately 100 participants with DS-TB who meet all the inclusion criteria and none of the exclusion criteria, aged 18 to 65, inclusive. Participants will be randomised to one of the 2 sorfequiline, pretomanid and linezolid containing regimens and will be randomised in 1:1 ratio based on country and severity of disease (AFB 3+ and/or bilateral cavitation). T

The trial will consist of the following periods:

  1. Screening period: Screening visit, up to 11 days prior to randomisation (Day 1)

  2. Treatment Period: approximately 100 participants will be randomised equally to the 2 treatment arms below:

    • Sorfequiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 4 weeks followed by sorfequiline 100 mg for 13 weeks
    • Sorfequiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 17 week
  3. Follow-up Period: 52 weeks after end of treatment

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sør-Afrika
      • East London, Sør-Afrika, 5201
        • Har ikke rekruttert ennå
        • Synergy Biomed Research Institute
        • Hovedetterforsker:
          • Mookho Malahleha, MD
        • Ta kontakt med:
    • Durban
      • Wentworth, Durban, Sør-Afrika, 4052
        • Rekruttering
        • Durban International Clinical Research Site
        • Ta kontakt med:
        • Hovedetterforsker:
          • Umesh Lalloo, MD
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sør-Afrika, 6200
        • Rekruttering
        • Isango Lethemba TB Research Unit
        • Hovedetterforsker:
          • Simone Faesen, MD
        • Ta kontakt med:
    • Gauteng
      • Soshanguve, Gauteng, Sør-Afrika, 0152
        • Rekruttering
        • Setshaba Research Centre
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zinhle Zwane, MD
    • Mowbray
      • Cape Town, Mowbray, Sør-Afrika, 7700
        • Rekruttering
        • University of Capetown Lung Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sherman Padayachee, MD
    • North West
      • Rustenburg, North West, Sør-Afrika, 2999
        • Rekruttering
        • The Aurum Institute, Rustenburg
        • Ta kontakt med:
          • William Brumskine, MD
        • Hovedetterforsker:
          • William Brumskine, MD
        • Ta kontakt med:
    • North West Provinvce
      • Brits, North West Provinvce, Sør-Afrika, 0250
        • Rekruttering
        • Madiberg Centre for Research
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lindsey Faul, MD
    • Northwest Province
      • Klerksdorp, Northwest Province, Sør-Afrika, 2571
        • Har ikke rekruttert ennå
        • Perinatal HIV Research Unit, Tshepong Hospital
        • Ta kontakt med:
        • Ta kontakt med:
  • Tanzania
      • Dar es Salaam, Tanzania
        • Har ikke rekruttert ennå
        • INUKA Africa
        • Ta kontakt med:
        • Hovedetterforsker:
          • Frederik Haraka, MD
      • Mbeya, Tanzania
        • Har ikke rekruttert ennå
        • NIMR-Mbeya
        • Ta kontakt med:
        • Hovedetterforsker:
          • Christina Manyama, MD
      • Moshi, Tanzania
        • Har ikke rekruttert ennå
        • Kilimanjaro Clinical Research Institute(KCRI)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Blandina Mmbaga, MD
      • Mwanza, Tanzania
        • Har ikke rekruttert ennå
        • NIMRI-Mwanza
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kidola Jeremiah, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB
  • Of non-childbearing potential OR using effective birth control methods
  • Body weight ≥ 35 k

Exclusion Criteria:

  • Karnofsky score < 60 at screening
  • Any evidence of extrapulmonary TB
  • Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding

  • Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:

    • CD4+ count<200 cells/μL.
    • WHO Clinical Stage 4 HIV disease
    • Participant does not agree to use DTG/TFV/3TC during study treatment if ARV therapy is indicated
    • If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sorfequline 200/100-Pretomanid 200mg-Linezolid 600mg (Loading Dose)

Regimen (17 weeks total):

Weeks 1-4: Sorfequiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Weeks 5-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily
Legemiddel: sorfequiline
Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)
Andre navn:
  • S
  • TBAJ876
Legemiddel: Pretomanid
one 200mg tablet taken once daily for 17 weeks
Andre navn:
  • P
  • PA-824
  • Dovprela
Legemiddel: Linezolid
one 600mg tablet taken once daily for 17 weeks
Andre navn:
  • Zyvox
  • L
  • Linospan
  • Linosept
  • Lizolid
Eksperimentell: Sorfequiline 100-Pretomanid 200mg-Linezolid 600mg (No Loading Dose)

Regimen (17 weeks total):

Weeks 1-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Includes sorfequiline placebo tablets during first 4weeks to maintain blinding vs the loading regimen.
Legemiddel: sorfequiline
Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)
Andre navn:
  • S
  • TBAJ876
Legemiddel: Pretomanid
one 200mg tablet taken once daily for 17 weeks
Andre navn:
  • P
  • PA-824
  • Dovprela
Legemiddel: Linezolid
one 600mg tablet taken once daily for 17 weeks
Andre navn:
  • Zyvox
  • L
  • Linospan
  • Linosept
  • Lizolid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and characterization of treatment-emergent adverse events (TEAEs)
Tidsramme: Through 17 weeks of treatment
Includes severity, relationship to study drugs, seriousness, TEAEs leading to discontinuation, and TEAEs leading to death; plus safety monitoring endpoints (ECG, vital signs, clinical labs, visual acuity changes, peripheral neuropathy changes.
Through 17 weeks of treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to stable sputum culture conversion (SSCC) to negative
Tidsramme: Through 17 weeks of treatment
SSCC defined as two negative cultures at least 7 days apart without an intervening MTB-positive result (protocol definition used for time-to-event analyses). Time Frame: Through 17 weeks of treatment
Through 17 weeks of treatment
Proportion with favorable outcome
Tidsramme: 26 weeks after EOT; 52 weeks after EOT
Favorable outcome assessed post-treatment; protocol includes evaluation at 26 weeks and 52 weeks after end of treatment
26 weeks after EOT; 52 weeks after EOT

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Global Alliance for TB Drug Development

Etterforskere

  • Studieleder: Morounfolu Olugbosi, TB Alliance

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. juli 2026

Primær fullføring (Antatt)

28. mai 2027

Studiet fullført (Antatt)

24. juni 2028

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

26. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NC-010

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to TB Alliance before submission. This allows TB Alliance to protect proprietary information and to provide comments; such consent will not be withheld unreasonably . Finalized results are published following completion of the trial. At that time, requests for the IPD can be made to C-Path at https://c-path.org/tools-platforms/tb-pacts/

IPD-delingstidsramme

IPD will be available post trial completion

Tilgangskriterier for IPD-deling

Researchers will be able to access the IPD (datasets) and supporting information through C-path URL.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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