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NCT07419373 · ClinicalTrials.gov registry record · Phase 2
ARN-75039 Lassa Fever Treatment in West Africa
A Phase 2 study of Lassa Fever, sponsored by Arisan Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 135
- Enrollment target
- 4
- Study locations
NCT07419373: Recruiting Phase 2 study of Lassa Fever, sponsored by Arisan Therapeutics.
NCT07419373 is a Phase 2 study of Lassa Fever that is actively recruiting participants, run by Arisan Therapeutics. The registered enrollment target is 135 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07419373, a Phase 2 study of Lassa Fever, is actively recruiting participants, sponsored by Arisan Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 135 participants
- Enrollment target
- 4
- Study locations
Study Summary
This multicenter, randomized, open-label Phase 2 clinical trial evaluates the safety, tolerability, and virologic efficacy of ARN-75039, a novel oral antiviral, for treating Lassa fever in hospitalized adults in West Africa. The study is conducted within the INTEGRATE platform and compares two oral dose regimens of ARN-75039 (100 mg BID and 50 mg BID) with intravenous ribavirin, the locally mandated standard of care. Approximately 135 participants with RT-PCR-confirmed Lassa virus infection will be enrolled and randomized 1:1:1 to receive ARN-75039 high dose, ARN-75039 low dose, or ribavirin for 10 days, followed by safety and efficacy follow-up through Day 28. The primary objectives are to assess safety and tolerability and to evaluate antiviral activity, as measured by the change in slope of Lassa virus RT-PCR cycle threshold (Ct) values from Day 1 to Day 10, in participants with low baseline viral load Ct values. Secondary objectives include additional virologic, pharmacokinetic, and clinical outcome assessments, including time to viral clearance, symptom resolution, organ failure, and mortality. ARN-75039 is a small-molecule viral entry inhibitor targeting the Lassa virus glycoprotein complex and has demonstrated potent antiviral activity and favorable safety and pharmacokinetic profiles in preclinical models and Phase 1 clinical studies. This study aims to inform dose selection and support further clinical development of ARN-75039 as a potential treatment for Lassa fever.
Conditions Studied
Interventions
- DRUG ARN-75039 high
- DRUG Intravenous ribavirin
- DRUG ARN-75039 low
Study Locations (4)
Other
- Abubakar Tafawa Balewa University Teaching Hospital - Bauchi
- Irrua Specialist Teaching Hospital - Irrua
California
- Arisan Therapeutics - Carlsbad
Ondo State
- Federal Medical Centre, Owo - Owo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2026-02 |
| Est. Completion | 2027-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07419373
The ClinicalTrials.gov registry entry for NCT07419373 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The listed sponsor is Arisan Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lassa Fever appearing as the primary indexed condition, and to 3 interventions - of which ARN-75039 high is the first listed.
NCT07419373 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Ondo State.
Frequently Asked Questions
What is clinical trial NCT07419373 about?
NCT07419373 is a clinical study titled "ARN-75039 Lassa Fever Treatment in West Africa". This multicenter, randomized, open-label Phase 2 clinical trial evaluates the safety, tolerability, and virologic efficacy of ARN-75039, a novel oral antiviral, for treating Lassa fever in hospitalized adults in West Africa. The study is conducted within the INTEGRATE platform and compares two oral ...
What is the current status of trial NCT07419373?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 135 participants. The study started on 2026-02. Estimated completion is 2027-06.
What conditions does trial NCT07419373 study?
This clinical trial studies the following conditions: Lassa Fever.
What interventions are being tested in trial NCT07419373?
The interventions under investigation include: ARN-75039 high (DRUG), Intravenous ribavirin (DRUG), ARN-75039 low (DRUG).
Who is sponsoring clinical trial NCT07419373?
This trial is sponsored by Arisan Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07419373 being conducted?
This trial has 4 study locations across California, Ondo State. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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