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NCT06508021 · ClinicalTrials.gov registry record · Phase 2

A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)

A Phase 2 study of Fibrodysplasia Ossificans Progressiva, sponsored by Ashibio.

Active
Registry status
Phase 2
Development phase
92
Enrollment target
3
Study locations

NCT06508021 is a Phase 2 study of Fibrodysplasia Ossificans Progressiva that is active but no longer recruiting, run by Ashibio. The registered enrollment target is 92 participants, above the 81-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (14% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT06508021, a Phase 2 study of Fibrodysplasia Ossificans Progressiva, is active but no longer recruiting, sponsored by Ashibio.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
92 participants
Enrollment target
3
Study locations

Study Summary

This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research questions, including: * Safety of andecaliximab in participants with FOP * Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; HO) * Whether andecaliximab reduces the number or severity of flare-ups * Pharmacokinetics/pharmacodynamics (PK/PD): How much study drug is in your blood at different times and its impact on blood biomarker(s) * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Interventions

  • DRUG Placebo
  • DRUG Andecaliximab

Study Locations (3)

California

  • University of California San Francisco (UCSF) - San Francisco

Minnesota

  • Mayo Clinic - Rochester

Pennsylvania

  • University of Pennsylvania - Perelman Center for Advanced Medicine - Philadelphia

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2024-10-25
Est. Completion 2029-02-04
Phase Phase 2

Sponsor

Ashibio

2 total trials

What the Registry Record Tells You About NCT06508021

The ClinicalTrials.gov registry entry for NCT06508021 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 81-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (14% higher). The listed sponsor is Ashibio, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06508021 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Minnesota, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06508021 about?

NCT06508021 is a clinical study titled "A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)". This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research q...

What is the current status of trial NCT06508021?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2024-10-25. Estimated completion is 2029-02-04.

What conditions does trial NCT06508021 study?

This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.

What interventions are being tested in trial NCT06508021?

The interventions under investigation include: Placebo (DRUG), Andecaliximab (DRUG).

Who is sponsoring clinical trial NCT06508021?

This trial is sponsored by Ashibio, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06508021 being conducted?

This trial has 3 study locations across California, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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