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A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM ) Treated With Olorofim Plus Baseline SOC or Placebo Plus Baseline SOC (COCCIMETRICS)

14. juli 2026 opdateret af: F2G Ltd

COCCIMETRICS: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis (DCM) Treated With Olorofim Plus Baseline Standard of Care (SOC) or With Placebo Plus Baseline SOC

The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated coccidioidomycosis (DCM).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Valley Fever (coccidioidomycosis) is a serious fungal infection that can cause long-lasting symptoms.

Currently marketed antifungal drugs have limitations including limited dosage forms, drug-drug interactions (DDIs), and significant adverse reactions.

Olorofim is an antifungal candidate with a novel mechanism of action offering activity against resistant organisms, differences in safety profile, along with oral route of administration, predictable and reliable pharmacokinetic (PK) profile and limited potential for DDIs.

This study tests whether the Valley Fever-Patient Reported Outcome (VF-PRO) questionnaire can reliably measure symptom impacts and changes over time in patients with severe forms of the disease (disseminated coccidioidomycosis (DCM)). The study will also assess symptoms of DCM and their severity, and whether olorofim, is safe and can help people with DCM when given together with standard antifungal medications (also known as standard-of-care or SOC).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Angela Wardman
  • Telefonnummer: +44 (0)161 518 0401
  • E-mail: awardman@f2g.com

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male and female patients, English- or Spanish-speaking, aged ≥18 years and weighing ≥40 kg.
  • Patients with progressive or refractory disseminated coccidioidomycosis (DCM) involving extra-pulmonary sites with or without ongoing active disease in lungs.
  • Standard of Care therapy for DCM to date has included 2 different triazoles (with or without a course of intravenous amphotericin B).

Exclusion Criteria:

  • Patients who are unconscious.
  • Women who are pregnant or breastfeeding.
  • Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
  • Patients with or planned placement of indwelling CNS devices.
  • Patients receiving intrathecal amphotericin B at the time of study enrolment.
  • Coccidioidomycosis limited to fibro-cavitary pulmonary disease.
  • All bothersome DCM-related symptoms at study entry are due to irreversible damage (e.g., neurologic deficits due to stroke).
  • Other than cutaneous fungal infections treated topically and Pneumocystis jirovecii infections, patients with a second fungal infection requiring systemic antifungal treatment or prophylaxis.
  • Patients with microbiological findings or other potential conditions that are temporally related and suggest a different than study indication etiology for the clinical features.

  • Patients living with Human immunodeficiency virus (HIV) unless for at least 6 months prior to enrollment:

    1. Are receiving antiretroviral therapy AND
    2. Have no evidence of current clinical progression resulting from HIV infection.
  • Patients who have received prior treatment with olorofim/F901318.
  • Patients receiving treatment limited to supportive care due to predicted short survival time.
  • Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥500 msec, or at high risk for QT/QTc prolongation.
  • Evidence of hepatic dysfunction.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm A (olorofim, plus Standard of Care)
Arm A: receives oral olorofim + Standard of Care
Medicin: Olorofim
Arm A: Oral olorofim loading dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 followed by a maintenance dose of 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 168 (± 7 days)
Placebo komparator: Arm B (placebo comparator, plus Standard of Care)
Arm B: receives olorofim-matched placebo + Standard of Care
Medicin: Placebo
Arm B: Oral olorofim-matched placebo loading dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 followed by a maintenance dose of 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 168 (± 7 days)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in VF-PRO Mobility domain score
Tidsramme: Day 168
Change from baseline in VF-PRO Mobility domain score at the Day 168 (Week 24) study visit.
Day 168
Change from baseline in VF-PRO Daily Function domain score
Tidsramme: Day 168
Change from baseline in VF-PRO Daily Function domain score at the Day 168 (Week 24) study visit.
Day 168

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms
Tidsramme: Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
% of patients with a reduction in severity of at least one of their most bothersome baseline DCM-related symptoms, and no worsening of their other most bothersome baseline DCM-related symptoms, at the Day 28, Day 56, Day 84, Day 112, Day 140 and Day 168 (Weeks 4, 8, 12, 16, 20 and 24) study visits.
Day 28, Day 56, Day 84, Day 112, Day 140, Day 168
To monitor incidence of Adverse Events in both treatment arms
Tidsramme: up to the Day 168 study visit and 4-week Follow-up (FU)
up to the Day 168 study visit and 4-week Follow-up (FU)
To monitor incidence of Serious Adverse Events in both treatment arms.
Tidsramme: up to the Day 168 study visit and 4-week Follow-up (FU)
up to the Day 168 study visit and 4-week Follow-up (FU)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

F2G Ltd

Samarbejdspartnere

IQVIA RDS Inc.

Efterforskere

  • Ledende efterforsker: George R. Thompson, MD, University of California, Davis, School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • F901318/0037

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Coccidioidomycosis

Kliniske forsøg med Olorofim

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