Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06463587 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorTrial sites expanded: 148 → 153 locationsEligibility criteria expanded, about 25 words · Secondary endpoints: details revised at 2 of 11 entries · Collaborators: details revised at 1 of 1 entryShow 3 more changesShow less
Eligibility criteria expanded, about 25 words
Secondary endpoints: details revised at 2 of 11 entries
Collaborators: details revised at 1 of 1 entry
MinorTrial sites expanded: 145 → 148 locationsv28
MinorStudy sites: 144 to 145v27
MinorRe-verified, no change to tracked fieldsv26
MinorTrial sites expanded: 138 → 144 locationsv25
MinorPrimary completion pushed from May 19, 2028 to Aug 23, 2028Trial sites expanded: 133 → 138 locations · Completion pushed from Aug 19, 2030 to Nov 12, 2030 · Eligibility criteria expanded, about 97 words · 1 morev24Show 4 more changesShow less
Trial sites expanded: 133 → 138 locations
Completion pushed from Aug 19, 2030 to Nov 12, 2030
MinorEnrollment target: 240 to 264Completion date: Jul 23, 2030 to Aug 19, 2030 · Eligibility criteria expanded, about 164 words · Secondary endpoints revised (10)v15Show 3 more changesShow less
Minor5 versionsRe-verified since Feb 18, 2025, no change to tracked fieldsv10-v14
MinorStudy sites: 32 to 35v9
MinorStudy sites: 29 to 32v8
MinorStudy sites: 20 to 29v7
MinorStudy sites: 18 to 20v6
MinorStudy sites: 5 to 18v5
MinorStudy sites: 1 to 5v4
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 2 to 1 · Start date changed from estimate of Jun 17, 2024 to Jun 25, 2024v3Show 2 more changesShow less
Study sites: 2 to 1
Start date changed from estimate of Jun 17, 2024 to Jun 25, 2024
MinorPrimary completion date: Feb 14, 2029 to May 19, 2028Completion date: Feb 28, 2031 to Jul 23, 2030 · Collaborators expanded, about 7 wordsv2Show 2 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo. It will also investigate the sustained efficacy, the need for retreatment, and the long-term safety of oral cladribine in gMG. An additional component is included to characterize the Pharmacokinetics (PK) of the new cladribine formulation in gMG participants. This study is divided into 3 periods: the double-blind placebo control (DBPC) pivotal period, and 2 extensions, the blinded extension (BE) and the retreatment (RT) period. Furthermore, in trial interviews will be conducted as a sub-study to MyClad with a sub-set of participants to gain an in depth understanding of the participant cladribine treatment and study experience.