Study to Evaluate the Efficacy, Safety and Tolerability of 3% LTX-109 for Nasal Decolonisation of Staphylococcus Aureus

NCT05889351 | Completed Phase 2

• 1 other identifier: C22-109-08
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase IIa, double-blind, placebo-controlled, randomised study designed to evaluate the efficacy, safety and tolerability of two dosing regimens with LTX-109 administered topically to the anterior nares in subjects with persistent carriage of Staphylococcus aureus (S. aureus).

Conditions

Nasal Decolonization of Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• Operating Window Eradication

  Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 6 hours, from 6 to 12 hours after start of treatment (the "Operation Window").

  6 hour to 12 hours after start of treatment

Secondary Outcomes (8)

• Number eradicated at specific timepoints

  4.5 hours, 6 hours, 12 hours

• Percentage change in colony forming units (CFUs) in subjects from baseline

  4.5 hours, 6 hours, 12 hours

• Number of subjects on LTX-109 versus placebo with bacterial eradication period lasting for 48 hours

  From 6 hours to 54 hours after start of treatment

• Adverse events

  Through treatment and followup of 7 days

• Local tolerability assessed by health care professional

  Pre-dose, 1.5 hours, 4.5 hours, 6 hours, 12, hrs, 54 hours and Day 7

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Vehicle treatment

Drug: Vehicle gel, 4 + 4 applications or 4 + 2 applications

Cohort 1

ACTIVE COMPARATOR

For all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 1, this was followed by 4 additional applications: on Day 1 at 12 hours, on Day 2 at 24 and 36 hours, and on Day 3 at 48 hours.

Drug: LTX-109 3% gel, 4 + 4 applications

Cohort 2

ACTIVE COMPARATOR

For all subjects, the IMP was applied 4 times during an intensive dosing regimen for 4 ½-hours (on Day 1 at 0, 1 ½, 3 and 4 ½ - hours). For subjects in Cohort 2 the IMP was likewise applied 4 times during the 4 ½-hour period (on Day 1 at 0, 1 ½, 3 and 4½ hours), but was followed by 2 applications: on Day 1 at 12 hours and on Day 2 at 36 hours.

Drug: LTX-109 3% gel, 4 + 2 applications

Interventions

Vehicle gel, 4 + 4 applications or 4 + 2 applications DRUG

Control arm/placebo

Placebo

LTX-109 3% gel, 4 + 4 applications DRUG

Cohort 1 active treatment

Cohort 1

LTX-109 3% gel, 4 + 2 applications DRUG

Cohort 2 active treatment

Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Male or female subject aged 18 to 65 years, inclusive.
• Persistent nasal carrier of S. aureus (MSSA), confirmed by 2 positive bacterial cultures from the nose during the screening period.
• Medically healthy subjects without abnormal clinically significant medical history, physical findings, vital signs, or laboratory values at the time of screening, as judged by the Investigator.
• Women of child bearing potential (WOCBP) had to practice abstinence (only allowed when this was the preferred and usual lifestyle of the subject) or had to agree to use a highly effective method of contraception with a failure rate of \< 1% to prevent pregnancy from the date of dosing until 2 weeks after last dose. Female subjects had to refrain from donating eggs from the date of dosing until 3 months after dosing with the IMP. Their male partner had to agree to use a condom from date of first dosing until 2 weeks after last dose if he had not undergone vasectomy.
• Male subjects had to be willing to use condom or had to be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and had to refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP. Their female partner of child-bearing potential had to use contraceptive methods with a failure rate of \< 1% to prevent pregnancy (see above).

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IMP.
• Severe eczema or skin wounds, dry or sensitive skin assessed as clinically significant by the Investigator.
• Any positive result at screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to LTX-109 or chlorhexidine.
• S. aureus (MSSA and/or MRSA) decolonisation attempt in the 6 months prior to - MRSA positive at screening (Visit 1 and/or Visit 2).
• Inability to take medications nasally.
• Nasal polyps or significant anatomical nasal abnormality, as judged by the Investigator.
• Evidence of open wound, lesion, inflammation, erythema or infection (including active rhinitis, sinusitis or upper respiratory infection or severe acne vulgaris) affecting the nostril area, lip and skin close to the nose.
• History of multiple episodes (\>3) of epistaxis within 12 months prior to screening Visit 2.
• Disease in the region of the application sites, significant history of trauma or skin disease in the region of the application sites, current nasal skin or nasal septum condition requiring treatment or nasal surgery in the 6 months prior to screening Visit 2.
• In situ nasal jewellery or open nasal piercings.
• Previous or concurrent treatment with antimicrobials for an infection within the last 28 days prior to the first administration of IMP.

Sponsors & Collaborators

• Pharma Holdings AS: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

ClinSmart Sweden AB

Uppsala, SE-752 37, Sweden

Location

MeSH Terms

Interventions

L-arginyl-2,5,7-tris(1,1-dimethylethyl)-L-tryptophyl-N-(2-phenylethyl)-L-argininamide; Gels

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Johan Nilsson, MD, Phd

  ClinSmart AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, Double-blind, Placebo-controlled Randomization 2:1, active to placebo

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 5, 2023
• Study Start: September 19, 2022
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)