Are you living with Kennedy's Disease?

If so, consider joining the PIONEER-KD study, a clinical trial investigating a new potential treatment for adults with Kennedy's Disease.

Study Overview

What is the PIONEER-KD study?

The PIONEER-KD clinical research study is for adults who have Spinal and Bulbar Muscular Atrophy (SBMA), also known as Kennedy's Disease. This study aims to investigate if the study medication, NIDO-361, is safe, well-tolerated, and effective when taken by patients with Kennedy's Disease.

Who can join the PIONEER-KD study?

Patients suffering from Kennedy's Disease may be able to join the study if they meet the following requirements:

Male; 18-70 years of age

Confirmed genetic diagnosis of SBMA

Must have the ability to walk independently or with a walking aid for 6 minutes

Other study requirements will apply.

What will happen during the study?

Participation in the PIONEER-KD study lasts approximately 13.5 months. Study participants can expect the following:

Review & Sign the Informed Consent Form
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Screening (up to 28 days)
Receive study health assessments to confirm if you qualify for the study such as MRI scans, blood and urine tests.
Study Treatment Period
Patients will be chosen at random to receive the study medication tablet or placebo which will be administered orally for 12 months. Patients will return to clinical sites monthly for check-ups and refilling tablets.
Follow-up Period
Patients will return to the clinic to receive follow-up study health assessments two weeks after the last study dose.

Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.

NIDO-361

What is NIDO-361?

The investigational study medication, NIDO-361, is designed to correct the function of the androgen receptor and help restore muscle strength and endurance in adults living with Kennedy's Disease. The PIONEER-KD study will investigate the safety and efficacy of NIDO-361 as a potential treatment.

Will I receive NIDO-361?

Participants will be chosen at random to receive either NIDO-361 or placebo. A single dose of the assigned treatment will be taken orally every day, in tablet form, for a duration of 12 months.

What is an “investigational medicine?"

Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the PIONEER-KD study.

Stock Photos. Posed by models.

Kennedy's Disease

What is Kennedy's Disease / Spinal and Bulbar Muscular Atrophy (SBMA)?

SBMA, also known as Kennedy's Disease, is a genetic neuromuscular disorder that occurs in men usually between 20-50 years old. Kennedy's Disease primarily affects your neuromuscular system causing loss of strength and movement, and affects reproductive tissues causing reduced fertility.

Stock Photos. Posed by models.

About Clinical Research

Here are some common questions and answers about study participation.

If you have additional questions about participating in a clinical research study, contact a study clinic near you.

Study Clinic Locations

Find a study clinic near you!

Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.

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