Repository for Genetic & Biomarker

Shannon Stevens, BSN, BS, CNRN, RN

(332) 334-6637

ALS

This study shares blood specimens with co-investigators for discovery of the basis of disease and new genetic variants.

A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) (ASTRALS)

Shannon Stevens, BSN, BS, CNRN, RN

(332) 334-6637

ALS

Recruiting complete.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB) 40-week treatment period followed by an open label extension (OLE).

A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects with Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)

Samantha Hefferman, FNP-BC

(332) 334-6637

ALS

Recruiting

This is a Phase IIB, randomized, double-blind, placebo-controlled study designed to assess the effects of PHENOGENE-1A (oral inhalation via dry powder inhaler [DPI]) in subjects with mild to moderate ALS disease. Eligible subjects will be randomized to receive either low dose PHENOGENE-1A (34.2 mg per day: in 2 doses of 17.1 mg and matching placebo BID), high dose PHENOGENE-1A (68.4 mg per day: 34.2 mg BID), or placebo (2 matching placebo capsules BID) (see table below), in a 2:2:1 ratio. Subjects will receive treatment for a duration of 24 weeks. All subjects must be on a stable dose of Riluzole 50 mg BID (100 mg daily) for at least 4 weeks prior to randomization and must continue their Riluzole regimen, 50 mg BID (100 mg daily), as standard-of-care treatment, throughout the 24 week treatment period.

A Phase 2b, Multi-center, Randomized, Double-blind,Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Samantha Heffernan, FNP-BC

(332) 334-6637

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Recruiting

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)

Samantha Heffernan, FNP-BC

(332) 334-6637

Myasthenia gravis

Recruiting

A phase 3 study in patients with myasthenia gravis using CAR-T cell therapy which modifies the patient’s T cells – key components of the immune system – to selectively target and suppress the immune responses that are believed to be responsible for the clinical manifestations of generalized myasthenia gravis.

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

Samantha Heffernan, FNP-BC

(332) 334-6637

Myasthenia Gravis

Recruiting

This is a 26-week study to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.