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ARN-75039 Lassa Fever Treatment in West Africa
NCT07419373 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arisan Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07419373 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Ondo State. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07419373?
The interventions under investigation include: ARN-75039 high (DRUG), Intravenous ribavirin (DRUG), ARN-75039 low (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07419373?
This trial is sponsored by Arisan Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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