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Myasthenia GravisPhase 1/2NCT06106672

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis

A Phase 1/2 study testing CNP-106 in people with Myasthenia Gravis and Generalized Myasthenia, run by COUR Pharmaceutical Development Company, Inc. at 17 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CNP-106
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
17 sitesUnited States
Study dates
30 May 2024to Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
  • Men and non-pregnant women, ages 18-75 years inclusive.
  • Female subjects of childbearing potential must agree not to become pregnant during the clinical study, have a negative pregnancy test at Screening Visit, and agree to one of the following:
  • Use two highly effective forms of birth control starting at initial screening and continuing throughout the study duration.
  • Practice abstinence starting at initial screening and continuing throughout the study duration.
  • Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class II-IV.
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  • Subjects positive for anti-AChR antibodies by radioimmunoassay (RIA) (LabCorp Central Laboratory Services Inc.).
  • Subjects with MG-ADL Score ≥6 at Screening and Baseline Visit with ≥50% of the score derived from non-ocular symptoms.
  • Subjects with QMG Score ≥11 at Screening and Baseline Visit.
  • For subjects on any medication used to treat the symptoms of MG (e.g. Corticosteroids, pyridostigmine), subjects must be on a stable dose for a minimum of 90 days prior to enrollment and must agree not to increase their dose throughout the study duration unless reviewed and approved by the medical monitor and the site investigator.
  • Female subjects who agree to not breastfeed starting at initial screening and throughout the study duration.
  • Female subjects who agree to not donate ova starting at initial screening and throughout the study duration.
  • Male subjects with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the study duration.

Who cannot join

  • Subjects with a Myasthenia Gravis Foundation of America Clinical Classification Class I or V.
  • Subjects with a history of cerebrovascular accident in the past 12 months.
  • Subjects with MG-ADL Score <6 at Screen or Subjects with MG-ADL Score ≥6 at Screen with ˂50% of the score derived from non-ocular symptoms.
  • Subjects with QMG Score <11 at Screen.
  • Subjects may enter the study following the washout periods for medications as described below prior to screening and refrain from usage throughout the study:
  • Tacrolimus within 6 months
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  • Azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 90 days
  • Anti-FcRn therapies:
  • Cyclic Anti-FcRns (e.g., efgartigimod alfa, rozanolixizumab) within 50 days
  • Chronic Anti-FcRns (e.g., nipocalimab) within 80 days;
  • C5 complement inhibitor (e.g., eculizumab) within 90 days
  • Anti-CD20 (e.g., rituximab) within 6 months;
  • Other immunomodulatory drugs will be at the discretion of the medical monitor and study site investigator.
  • Subjects who have used immunoglobulins given SC or IV (SCIg or IVIg) or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
  • Subjects who have had thymectomy or any other thymic surgery performed within 12 months prior to Screening.
  • Subjects with untreated thymic malignancy, carcinoma, or thymoma.
  • Subjects with a history of untreated tuberculosis, a positive PPD skin test, or a positive QuantiFERON test.
  • Subjects with documented evidence of satisfactory TB treatment can be considered after review with the medical monitor and documentation of treatment course.
  • Subjects who have received administration of any live vaccine (other than intranasal Influenza) within 28 days or subunit vaccine within 14 days prior to Screening or are planning to receive any vaccination throughout the study duration.
  • Subjects who have received any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the first dose of any COVID-19 vaccine may not screen for the study until 14 days following their last dose of the vaccine if applicable.
  • Subjects with laboratory test results at Screening or prior to study dosing that are outside the normal limits and considered by the investigator to be clinically significant. Note: Clinically significant laboratory test results at screening that are related to the condition (MG) are acceptable if all inclusion and no other exclusion criteria are met.
  • Subjects with positive test results for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody as determined at Screening.
  • Subjects with a history of or currently active immune disorders other than MG (including autoimmune disease) unless the condition, after discussion with the medical monitor and study site investigator, has been deemed to be acceptable for the subject's participation in this clinical study.
  • Subjects with a history of or current active diseases other than myasthenia gravis requiring immunosuppressive drugs (including azathioprine, prednisone, prednisolone, budesonide, cyclosporine, tacrolimus, methotrexate, or mycophenolate mofetil) unless the condition, after discussion with the medical monitor and site investigator, has been deemed to be acceptable for the subject's participation in this clinical study.
  • Subjects with a clinical history of significant cardiovascular disease as determined by the Investigator.
  • Subjects with a complication or medical history of malignancy within the past 5 years which, in the investigator's opinion, makes the subject unsuitable for study participation.
  • Subjects with a history of mast cell activation disease.
  • Subjects who, in the investigator's opinion, will be unable to adhere to study procedures.
  • Subjects who have received an investigational therapy other than CNP-106 within 28 days or 5 half-lives, whichever is longer, prior to Screening.
  • Subjects with any known active condition which, in the investigator's opinion, makes the subject unsuitable for study participation.
  • Known sensitivity to any components of CNP-106 (PLGA, sucrose, mannitol, or sodium citrate).

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Infusion for Health

    Brea, California, 92835

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Insight Hospital and Medical Center

    Chicago, Illinois, 60608

  • Ohio State University Wexner Medical Center

    Colombus, Ohio, 43221

  • University of Missouri, NextGen Precision Health

    Columbia, Missouri, 65211

  • Insight Research Institute, Dearborn

    Dearborn, Michigan, 48126

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Atlantis Research

    Miami, Florida, 33173

  • Quantix Research, LLC

    Miami, Florida, 33173

  • Yale University

    New Haven, Connecticut, 06516

  • University of California, Irvine

    Orange, California, 92868

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • University of California, Davis

    Sacramento, California, 95817

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-106 in Subjects Ages 18-75 With Generalized Myasthenia Gravis

Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106.

Read the detailed description

This is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-106. The clinical study lasts 222-days (up to 42 days for Screening, 180 Study Days). Subjects ages 18-75 with generalized myasthenia gravis (MG) will be screened up to 42 days prior to enrollment into the clinical study.

Being tested
CNP-106, Placebo
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNP-106Drug

    CNP-106 is comprised of an antigenic AChR Peptide Pool (~1 μg of each AChRα and AChRε peptide comprising AChR Peptide Pool Drug Substance per mg particles) dispersed within a negatively charged (-30 to -60 mV) polymer matrix of PLGA (Poly (DL-lactide-co-glycolide, 50:50 acid-end group)) particles (400-800 nm in size).

  • PlaceboOther

    CNP-106 Placebo

Study groups in NCT06106672
Study groupRoleWhat they receive
CNP-106Experimental200 mL intravenous infusion on Day 1 and Day 8: CNP-106
Receives: Drug: CNP-106
PlaceboPlacebo comparatorCNP-106 Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs),

    Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to COUR Pharmaceuticals Development Company, Inc. Confidential CNP-106-5.001 Protocol; IND 28774 Page 53 of 65 discontinuation from IP and study, by severity, and by causality. No formal statistical testing will be done.

    Measured: Through study day 180

Secondary outcomes (2)

  1. Change from baseline in antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180.

    The mean change from Baseline to the endpoint within CNP-106 and Placebo treatment groups will be analyzed using ANOVA.

    Measured: Through study day 180

  2. Change from baseline in activated antigen specific CD4+ and CD8+ T cell levels in PBMC at Day 60, 90, and 180.

    The mean change from Baseline to the endpoint within CNP-106 and Placebo treatment groups will be analyzed using ANOVA.

    Measured: Through study day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start30 May 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106672
Sponsor's protocol ID
CNP-106-5.001
Status last verified
Jun 2026
First submitted
24 Oct 2023
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • G Brew S, Frey M, P McCarthy D, Elhofy A, Nowak RJ. Antigen-specific immune therapy (CNP-106) for treatment of generalised myasthenia gravis: rationale and design of first-in-human randomised controlled trial. BMJ Neurol Open. 2024 Dec 18;6(2):e000836. doi: 10.1136/bmjno-2024-000836. eCollection 2024.

    PubMed 39720510

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CNP-106 in people with Myasthenia Gravis and Generalized Myasthenia, run by COUR Pharmaceutical Development Company, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs), (time frame: Through study day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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