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SARACATINIB

SARACATINIB is being studied in clinical trials for people with Fibrodyplasia Ossificans Progressiva (FOP), a rare condition linked to abnormal bone formation. The trial data focus on safety, tolerability, and whether SARACATINIB can reduce new bone lesions. The study includes adults with FOP and compares SARACATINIB with placebo.

Table of contents

Clinical trial overview

The available trial for SARACATINIB is a study in Fibrodyplasia Ossificans Progressiva (FOP), a rare condition with abnormal bone formation.[1] The study is designed to judge safety, tolerability, and effects on new bone formation.[1]

Who the trial is for

This trial is for patients with FOP.[1] The source data do not list more detailed entry rules, so the main known target group is people living with this condition.[1]

Study design and treatment groups

The study is an interventional trial, which means researchers give a study treatment and then measure what happens.[1] It is a Phase 2 trial, so it is looking for early signs that the treatment may help while also checking safety.[1]

The intervention listed is AZD0530, which is named in the source as SARACATINIB, and it is compared with a placebo tablet.[1] A placebo is a look-alike tablet without the study drug, used to help compare results fairly.[1]

What the trial measures

The main safety outcome is the incidence and severity of treatment-emergent adverse events through week 26.[1] This means the study counts side effects and looks at how serious they are during the treatment period.[1]

The main efficacy outcome is the number of new lesions, meaning new areas of abnormal bone formation.[1] The study measures these new active HO lesions with [18F]-NaF PET and also checks for new HO lesions with CT at week 26.[1]

HO stands for heterotopic ossification, which means bone forming in the wrong place.[1] In this trial, that is the main disease feature researchers want to track.[1]

Trial status and size

The trial status is listed as Authorised.[1] The planned enrollment is 18 patients, so this is a small study focused on a rare disease group.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT04307953Phase 2Fibrodyplasia Ossificans Progressiva (FOP)Authorised18

FAQ

  • What is being studied in the SARACATINIB trial? The trial is studying whether SARACATINIB can help reduce abnormal bone formation in people with FOP. It also checks safety and tolerability.
  • Who can take part in the trial? The trial is for patients with Fibrodyplasia Ossificans Progressiva (FOP). The source data do not give more detailed participation rules.
  • What phase is the SARACATINIB trial? This is a Phase 2 trial. Phase 2 studies usually look at early signs that a treatment may work, while also continuing to check safety.
  • What does the trial compare SARACATINIB with? The study compares SARACATINIB with placebo. A placebo is a look-alike treatment that does not contain the study drug.
  • What results are measured in the trial? The main results are safety, side effects that appear during treatment, and the number of new bone lesions. The study also uses PET and CT scans to look for new active lesions.

Igangværende kliniske forsøg for SARACATINIB

  • Test af lægemidlet saracatinib til behandling af unormal knoglevækst hos personer med FOP (fibrodysplasi ossificans progressiva)

    Rekrutterer ikke

    1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland Holland

Ordliste

  • Fibrodyplasia Ossificans Progressiva (FOP): A rare condition in which abnormal bone forms in places where it should not, such as muscles and soft tissues.
  • Clinical trial: A research study in people that tests whether a treatment is safe and whether it may help a condition.
  • Phase 2: A trial stage that looks at early signs of benefit and keeps checking safety in a smaller group of patients.
  • Safety: How well a treatment can be used without causing harmful problems.
  • Tolerability: How well people can take a treatment without it causing too much discomfort or difficulty.
  • Placebo: A look-alike treatment with no active study drug. It is used for comparison.
  • Adverse event: A medical problem or unwanted symptom that happens during a study, whether or not it is caused by the treatment.
  • Lesion: An area of abnormal tissue. In this study, it refers to new abnormal bone areas.
  • HO: Short for heterotopic ossification, which means bone forming in the wrong place.
  • PET scan: An imaging test that shows active processes in the body. Here it is used to look for active new bone lesions.
  • CT scan: A detailed imaging test that can show body structures, including new bone changes.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/test-af-laegemidlet-saracatinib-til-behandling-af-unormal-knoglevaekst-hos-personer-med-fop-fibrodysplasi-ossificans-progressiva/