RUTI®
Candidate Overview
RUTI® is a liposome suspension of the drug substance with a charge excipient. The drug substance is based on cell wall nanofragments of Mycobacterium tuberculosis. It contains a wide mixture of antigens obtained by a M. tuberculosis growth under stress conditions.
Sponsor / Lead Developer: Archivel Farma, S.L
Clinical Trial Status: Active Trials
Primary Indication: Immunotherapy / Shortening TB treatment
Other Indication(s): Immunotherapy/Improving TB Cure Rates, Prevention of TB disease, and Prevention of TB recurrence
Target Population(s): Adolescents, Adults, People cured of active TB, People with active TB, People with MDR-TB, and People with Mtb infection
Target Route of Administration: Subcutaneous
Clinical Trials
ACTIVE TRIALS |
|
| Registry Number | NCT04919239 |
| Clinical Trial Phase | Phase 2b |
| Clnical Trial Sponsor | Archivel Farma S.L. |
| Primary endpoint(s) for this clinical trial | Improved treatment outcomes |
| Target population(s) for clinical trial | Adults |
| People with MDR- TB |
|
| People with active TB | |
_________________________ |
|
| Registry Number | NCT05455112 |
| Clinical Trial Phase | Phase 2b |
| Clinical Trial Sponsor | Archivel Farma S.L. |
| Primary endpoint(s) for this clinical trial | Improved treatment outcome |
| Target population(s) for clinical trial | Adults |
| People with active TB | |
COMPLETED TRIALS |
|
| Registry Number | NCT01136161 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Archivel Farma S.L. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People with Mtb infection | |
_________________________ |
|
| Registry Number | NCT00546273 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Germans Trias i Pujol Hospital |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
OTHER TRIALS |
|
| Registry Number | NCT02711735 |
| Clinical Trial Phase | Phase 2a |
| Clincal Trial Status | Terminated (lack of recruitment - see notes) |
| Clincal Trial Sponsor | Archivel Farma S.L. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
| People with MDR-TB | |
Related Publications
- RUTI Vaccination Enhances Inhibition of Mycobacterial Growth ex vivo and Induces a Shift of Monocyte Phenotype in Mice (Front Immunol., 2019)
- Safety, Tolerability, and Immunogenicity of the Novel Antituberculous Vaccine RUTI: Randomized, Placebo-Controlled Phase II Clinical Trial in Patients with Latent Tuberculosis Infection (PLOS One, 2014)
- Double-blind, randomized, placebo-controlled Phase I Clinical Trial of the therapeutical antituberculous vaccine RUTI® (Vaccine, 2010)
Additional Information
A Phase 2a study (NCT02711735) of RUTI in adults with MDR-TB in Ukraine was terminated early due to lack of enrollment, however immunological data from study samples is pending evaluation and data from the study is currently under review.