TerminatedPhase 3

Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial

Stopped: As a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. The planned duration of open-label treatment was 40 months. After termination, the actual mean duration of treatment was approx. 28 weeks.

United States121 participantsStarted 2019-05-20

Plain-language summary

A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)

Who can participate

Age range45 Years

SexALL

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Inclusion criteria

✓. Patient is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures.
✓. Patient has completed the IBM4809 trial on treatment with Investigational Medicinal Product (IMP).

Exclusion criteria

✕. Known or suspected allergy or intolerance to arimoclomol or its constituents.
✕. Exposure to any other investigational treatment within 30 days or \<5 half-lives of the baseline visit or taking part or planning to take part in another interventional trial.
✕. Significant protocol deviation in the blinded IBM4809 trial based on the investigator's judgement in discussion with the medical monitor.
✕. Women who are lactating or pregnant, or men or women unwilling to use a highly effective method of birth control if not surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants up to 3 months after last dose. Premenopausal women must have a negative pregnancy test prior to dosing with trial medication. Acceptable methods of birth control are:
✕. Any concurrent condition that in the investigator's opinion will significantly interfere with assessment of safety or efficacy.
✕. Inability to comply with the protocol-specified procedures/evaluations and scheduled visits as per the investigator.

What they're measuring

Change in Inclusion Body Myositis Functional Rating Scale (IBMFRS) Total Score

Timeframe: Change from Baseline in IBM-OLE to Early Termination Visit (variable, an average of approximately 28 weeks).

Trial details

NCT IDNCT04049097

SponsorZevraDenmark

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-15

Results submitted2023-05-15

View on ClinicalTrials.gov More Inclusion Body Myositis trials