CompletedPhase 3

Open-label Treatment in Cushing's Syndrome

United States51 participantsStarted 2019-01-07

Plain-language summary

This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)
✓. Completed the Restoration Phase of Study COR-2017-01 (i.e. RES2)
✓. Currently in a named patient program or other Expanded Access Program receiving levoketoconazole
✓. Were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in Study COR-2017-01.
✓. Achieved a clinically meaningful partial response (with reduction of UFC) in Study COR-2017-01 at dose level 7 or at a maximally tolerated dose of levoketoconazole but did not meet the randomization criteria for Study COR-2017-01 at the end of the Dose Titration and Maintenance Phase when randomization was open.
✓. Were levoketoconazole-naïve prior to entry and were enrolled in Study COR-2017-01 in the Dose Titration and Maintenance Phase when randomization was closed. (NOTE: Such subjects must receive at least 1 dose of levoketoconazole before transitioning to this study.)

Proportions of Participants With Mean Urinary Free Cortisol (mUFC) Categorization Based on Upper Limit of Normal (ULN)

Timeframe: From parent study Baseline to final study visit or up to a maximum of 3 years, whichever comes first.

NCT IDNCT03621280

SponsorCortendo AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2025-06-04