Myclad (1)

MyClad Study in PhoenixA Clinical Trial Evaluating Oral Cladribine in Generalized Myasthenia Gravis

Arizona Neuroscience Research is now enrolling participants in the MyClad clinical trial, a Phase 3 study evaluating a new formulation of oral cladribine in adults with generalized myasthenia gravis.

The MyClad study is designed to assess the efficacy and safety of oral cladribine compared with placebo in participants with generalized myasthenia gravis, also known as gMG. The study is listed on ClinicalTrials.gov as NCT06463587 and is also identified by the study number MS7005680-0183.

For adults living with generalized myasthenia gravis in Phoenix and surrounding Arizona communities, clinical research may offer an opportunity to take part in a carefully monitored study while helping researchers learn more about investigational treatment approaches for gMG.

Arizona Neuroscience Research is a recruiting site for the MyClad study in Phoenix, Arizona. Patients interested in learning more can visit the Volunteer Today page or contact Arizona Neuroscience Research for current study criteria and screening details.

About the MyClad Study

The MyClad study is a Phase 3 clinical trial evaluating a new oral formulation of cladribine in adults with generalized myasthenia gravis.

According to the ClinicalTrials.gov study record, the purpose of the study is to determine the efficacy and safety of the new oral cladribine formulation in comparison to placebo. The study will also investigate sustained efficacy, the need for retreatment, and long-term safety of oral cladribine in generalized myasthenia gravis.

The study also includes a pharmacokinetics component. Pharmacokinetics, often shortened to PK, refers to how a study drug moves through the body. The ClinicalTrials.gov record states that this component is included to characterize the pharmacokinetics of the new cladribine formulation in participants with generalized myasthenia gravis.

In addition, the study includes trial interviews with a subset of participants to better understand the participant treatment and study experience.

Study Name

MyClad

Study Number

MS7005680-0183

ClinicalTrials.gov Identifier

NCT06463587

Condition

Generalized myasthenia gravis

Study Phase

Phase 3

Study Type

Interventional

Study Design

Randomized, double-blind, placebo-controlled, 3-arm, 3-period study

Study Treatment Groups Listed on ClinicalTrials.gov

Placebo

Cladribine low dose

Cladribine high dose

Sponsor

EMD Serono

What Makes This Study Important?

Generalized myasthenia gravis is the condition being studied in MyClad. The ClinicalTrials.gov record describes eligible participants as adults with a diagnosis of myasthenia gravis with generalized muscle weakness meeting Myasthenia Gravis Foundation of America Class II to IVa classification.

Clinical trials like MyClad are designed to answer structured research questions. In this study, researchers are evaluating whether a new oral formulation of cladribine may have efficacy and safety in participants with generalized myasthenia gravis when compared with placebo.

The study is not the same as standard treatment. It is clinical research. Participants must complete screening, meet eligibility criteria, and review the informed consent materials before deciding whether to participate.

The MyClad study website notes that in a clinical research study, participants may receive investigational medication that has not been approved by regulatory authorities, an approved comparator product or intervention, or placebo, depending on the study design. The website also notes that participants may not benefit from the study medication they are assigned to, and that the key known risks and requirements of participation will be described before a participant decides whether to take part.

How the MyClad Study Is Structured

The ClinicalTrials.gov record describes MyClad as a 3-arm, 3-period study. The study includes:

A double-blind placebo-controlled pivotal period

A blinded extension period

A retreatment period

This structure allows the study to evaluate the study medication compared with placebo, while also looking at longer-term questions such as sustained efficacy, possible need for retreatment, and long-term safety.

The study record also lists three intervention groups:

Placebo

Cladribine low dose

Cladribine high dose

Because this is a randomized, double-blind, placebo-controlled study, participants should understand that study assignment is determined by the study protocol and that placebo is part of the design. The informed consent process will explain the study design, possible risks, possible benefits, visit expectations, and participant responsibilities.

Who May Be Eligible?

Eligibility must always be confirmed by the study team. Not every person with generalized myasthenia gravis will qualify.

According to the ClinicalTrials.gov record, key inclusion criteria include:

Adults 18 years of age or older at the time of signing informed consent

Diagnosis of myasthenia gravis with generalized muscle weakness

Clinical criteria meeting Myasthenia Gravis Foundation of America Class II to IVa classification

Participants who are positive for acetylcholine receptor antibody, also known as anti-AChR, or muscle-specific kinase antibody, also known as anti-MuSK

Participants who are autoantibody seronegative or positive for anti-low-density lipoprotein receptor-related protein 4 antibodies, also known as anti-LRP4

Screening and baseline MG-ADL score greater than or equal to 6, with at least 50 percent of the total score due to non-ocular symptoms

The ClinicalTrials.gov record also states that healthy volunteers are not accepted.

Final eligibility depends on the full study protocol, medical history, current medications, study-specific inclusion and exclusion criteria, screening results, and review by the research team.

Who May Not Qualify?

The study record includes exclusion criteria. One listed example is a molecularly characterized or suspected congenital myasthenic syndrome, Lambert-Eaton myasthenic syndrome, inherited myopathy, muscular dystrophy, acquired myopathy, or another neurologic or systemic disease that mimics myasthenia gravis muscle weakness.

This is one reason screening is important. The research team must confirm that each participant fits the study criteria before enrollment.

What to Expect During Screening

Screening is the process used to determine whether a person may qualify for the study.

Potential screening steps may include review of:

Diagnosis

Medical history

Myasthenia gravis classification

MG-ADL score

Antibody status

Current medications

Prior treatments

General health

Study inclusion and exclusion criteria

The study team will explain what is required before any study-related procedures are performed. Participation is voluntary, and patients should ask questions before deciding whether to participate.

Questions to Ask Before Joining the MyClad Study

Patients considering the MyClad study may want to ask:

What is the purpose of this study?

What does randomized, double-blind, placebo-controlled mean for me?

What are the study treatment groups?

How long could participation last?

How often are visits required?

What tests or assessments are required?

Could I receive placebo?

What are the possible risks?

What are the possible benefits?

What happens if my symptoms worsen?

Can I leave the study?

Will I continue seeing my regular doctor?

Who do I contact with questions during the study?

Will there be any costs or compensation?

These questions are part of making an informed decision.

Why Participate in Clinical Research?

Clinical research helps answer important questions about investigational therapies, safety, efficacy, dosing, retreatment, long-term monitoring, and patient experience.

For MyClad, the study record states that researchers are evaluating a new oral cladribine formulation compared with placebo in generalized myasthenia gravis. The study is also looking at sustained efficacy, need for retreatment, long-term safety, pharmacokinetics, and participant experience through interviews in a subset of participants.

Participation in a clinical trial does not guarantee benefit. It does allow eligible participants to contribute to research under a structured study protocol.

MyClad in Phoenix, Arizona

Arizona Neuroscience Research is now enrolling participants in the MyClad clinical trial in Phoenix, Arizona.

ClinicalTrials.gov lists Arizona Neuroscience Research, LLC in Phoenix as a recruiting location for NCT06463587. The study record also lists Leslie Zuniga as principal investigator for the Phoenix site.

This gives patients in Phoenix and surrounding communities a local opportunity to ask about screening for the MyClad study.

Arizona Neuroscience Research serves patients and volunteers from Phoenix, Scottsdale, Tempe, Mesa, Chandler, Gilbert, Glendale, Peoria, Paradise Valley, Ahwatukee, and nearby Arizona communities.

How to Volunteer

Patients interested in the MyClad study can visit the Volunteer Today page to ask about current enrollment and screening.

Volunteer Today

Visit: /volunteer-today/

MyClad Study Website

https://www.mycladstudy.com

ClinicalTrials.gov

Search: NCT06463587

Study Name

MyClad

Study Number

MS7005680-0183

Condition

Generalized myasthenia gravis

Sponsor

EMD Serono

Frequently Asked Questions

What is the MyClad study?

MyClad is a Phase 3 clinical trial evaluating a new oral formulation of cladribine compared with placebo in adults with generalized myasthenia gravis.

What condition is being studied?

The study is evaluating generalized myasthenia gravis.

Is Arizona Neuroscience Research enrolling for MyClad?

Yes. Arizona Neuroscience Research is now enrolling participants for the MyClad clinical trial in Phoenix, Arizona.

What is the ClinicalTrials.gov number?

The ClinicalTrials.gov identifier is NCT06463587.

What is the study number?

The study number is MS7005680-0183.

Who may qualify?

Adults 18 years or older with generalized myasthenia gravis may be considered, but final eligibility depends on the study criteria and screening by the research team.

Can healthy volunteers join?

ClinicalTrials.gov states that healthy volunteers are not accepted for this study.

Will every participant receive oral cladribine?

No. The study includes placebo and cladribine dose groups. The study team will explain the study design and assignment process during informed consent.

Does participation guarantee benefit?

No. The MyClad study website states that participants may not benefit from the study medication they are assigned to.

How do I learn more?

Visit the Volunteer Today page or contact Arizona Neuroscience Research for current study criteria and screening information.

Schedule a Screening Conversation

If you are an adult with generalized myasthenia gravis and are interested in learning whether the MyClad study may be an option, Arizona Neuroscience Research can help you understand the next steps.

Participation is voluntary. Eligibility must be confirmed by the research team. The study team will review the requirements, possible risks, possible benefits, and study procedures before you decide whether to take part.

Visit /volunteer-today/ to ask about the MyClad study in Phoenix.

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MyClad Study Phoenix AZ
Oral Cladribine Clinical Trial for Generalized Myasthenia Gravis

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Arizona Neuroscience Research is enrolling adults with generalized myasthenia gravis for the MyClad study, a Phase 3 clinical trial evaluating oral cladribine compared with placebo.

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