Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06764160
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of MG must be made by the following tests:
1. Positive serologic test for anti-AChR Abs as confirmed at Screening, and
2. One of the following:
1. Abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or
2. History of positive anticholinesterase test, eg, neostigmine test, or
3. Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician
* MGFA Clinical Classification Class II to IV at Screening
* MG-ADL total score must be ≥ 6 at Screening and Day 1
* Participants who have:
1. Failed treatment with 2 or more ISTs over one year (either in combination or as monotherapy), ie, continue to have impairment ADLs (persistent weakness, experience crisis, or unable to tolerate IST) despite ISTs or,
2. Failed at least one IST and require chronic PE or IVIg to control symptoms, ie, participants who require PE or IVIg on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months
Exclusion Criteria:
* Any untreated thymic malignancy, carcinoma, or thymoma
* History of thymectomy or any other thymic surgery within 6 months prior to Screening. Participants with a history of treated thymic malignancy or carcinoma are eligible if they meet all of the following conditions:
1. Treatment completed \> 5 years prior to the Screening Visit
2. No recurrence within the 5 years prior to the Screening Visit
3. No radiological indication of recurrence in a computed tomography (CT) or magnetic resonance imaging (MRI) scan, including administration of intravenous (IV) contrast, performed within 6 months of first dose on Day 1
* Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
* MG crisis at Screening (MGFA Class V). However, such participants may be rescreened with Alexion approval once they are treated and medically stable, in the opinion of the Investigator
* History of N meningitidis infection or unresolved meningococcal disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06764160
Study Brief:
Protocol Section:
NCT06764160