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A Phase 1b Study to Investigate Safety and Tolerability of ARGX-119 in Adult Participants With DOK7-Congenital Myasthenic Syndromes (CMS)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: ARGX-119 (biological), Placebo (other)
How long the study runs: Study runs about 40 months (dates as stated)
About the drug or intervention: ARGX-119 — biological: Intravenous infusion of ARGX-119 · Placebo — other: Intravenous infusion of placebo
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years and over
Who: All
Number of participants: 15
Started: 2024-09-24
Last checked: 2026-07

Plain English Summary

What is this study?

• Testing a new treatment for congenital myasthenic syndrome
• Phase1 - 15 participants
• The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes

Who can take part?

• Ages 18 Years and over
• Diagnosed with congenital myasthenic syndrome

Where?

• Belfast - Clinical Trials Centre - South Eastern Health and Social Care Trust - The Ulster Hospital
• Oxford - John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to assess the safety and tolerability of ARGX-119 in adult participants with DOK7- Congenital Myasthenic Syndromes. The study will also assess how ARGX-119 is processed by the body (pharmacokinetics), how the immune system reacts to it (immunogenicity), and how it may improve the way patients feel and function. After the screening period, eligible participants will be randomized in a 4:1 ratio to receive intravenous infusions of ARGX-119 or placebo during the double-blinded treatment period. Participants will then enter the follow-up period. After the follow-up period, participants may enrol in the active-treatment period, where they will receive open-label ARGX-119. The full duration of the study is approximately 38 months.

Congenital Myasthenic SyndromeCMS

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

What the study is looking for

✓At least 18 years of age.
✓Has genetically confirmed congenital myasthenic syndromes due to mutation of downstream of kinase 7 (DOK7-CMS).

Who cannot take part

✗Diagnosis of CMS due to mutation of any gene other than DOK7.
✗Known medical condition that would interfere with an accurate assessment of CMS, confound the results of the study,...
✗Pregnant or lactating state or intention to become pregnant during the study.

See the full criteria

Inclusion Criteria: * At least 18 years of age. * Has genetically confirmed congenital myasthenic syndromes due to mutation of downstream of kinase 7 (DOK7-CMS). * Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) must have been receiving the medication for more than 3 months and agree to remain on a same stable dosing regimen of the same medication until the end of the study. Exclusion Criteria: * Diagnosis of CMS due to mutation of any gene other than DOK7. * Known medical condition that would interfere with an accurate assessment of CMS, confound the results of the study, or put the patient at undue risk, as assessed by the investigator. * History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for more than 5 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer. * Pregnant or lactating state or intention to become pregnant during the study.

Where Is This Study? (2 UK sites)

Clinical Trials Centre - South Eastern Health and Social Care Trust - The Ulster Hospital

Belfast BT16 1RH, United Kingdom

Hospital R&D contact (matched)

Stephanie Kelly

Research.Development@setrust.hscni.net 02895980075

John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk ---

Data sourced from ClinicalTrials.gov · Last verified: 2026-07