Recruiting
Phase 3

NIO752

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07498426

Conditions

Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Eligibility Criteria

Sex: All

Age: 41 - 70+

Healthy Volunteers: Not accepted

Interventions

NIO752

Placebo

Study Details

Brief summary:

This Phase III study is intended to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP). Eligible participants will be randomized to receive either NIO752 or placebo followed by an open-label extension.

Conditions

Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS)

Study ID

NCT07498426

Start date

Jun 3, 2026

Status verified date

Jul, 2026

Completion date

Jul 18, 2031

Anticipated

Primary completion date

Jul 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 41 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.
2. Male or female participants, age between 41-81 yrs inclusive.
3. Diagnosis of mild-moderate, probable/possible PSP Richardson syndrome as per MDS-PSP 2017 criteria with symptoms onset < 5 years.
4. PSPRS total score less than 40 at Baseline.
5. Reliable study partner such as spouse, sibling, close friend, or caregiver able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and to participate in study visits and informant-based assessments for the duration of the study. A reliable study partner is expected to spend enough time (at least 5 hours per week) with the study participant.
6. Participant is able to ambulate defined as the ability to take at least 10 steps independently or with minimal assistance (stabilization of one arm to minimize fall risk).
7. Mini Mental State Examination (MMSE) score ≥ 20 at Screening.

Exclusion Criteria:

1. Diagnosis of other significant neurological or psychiatric disorders including (but not limited to) Parkinsons' Disease (which has not subsequently been revised to a diagnosis of PSP); Alzheimer's disease (AD), dementia with Lewy bodies; prion disease; any psychotic disorders; severe Major depressive disorder; seizure; brain tumor or other space-occupying lesion; history of clinically significant stroke (e.g., stroke with permanent neurological deficit); history of head injury with loss of consciousness for at least 15 minutes within the past 20 years.
2. Diagnosis of amyotrophic lateral sclerosis or other motor neuron diseases.
3. Diagnosis of cerebellar ataxia, choreoathetosis, and early symptomatic autonomic dysfunction.
4. History of or screening brain MRI scan indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct >1 cm3, >3 lacunar infarcts, cerebral contusion, aneurysm, vascular malformation >1 cm3, subdural hematoma, hydrocephalus, and space-occupying lesion (e.g., abscess or brain tumor).
5. Contraindications to undergo MRI procedure, including metal (ferromagnetic) implants and/or a cardiac pacemaker that is not compatible with MRI.
6. Medical conditions that would, as per Investigator's judgement, prevent the participant from undergoing lumbar puncture, including but not limited to:

1. Known allergy to local anesthetic
2. History of back surgery (with the exception of microdiscectomy or laminectomy over 1 level)
3. Spinal deformities
4. Current dermatological infection at the lumbar puncture spot and/or significant skin alterations at the planned puncture place
5. Risk of increased or uncontrolled bleeding and/or risk of bleeding that if not managed optimally, could place a participant at an increased risk for procedural bleeding. These could include, but are not limited, to anatomical factors at or near the LP site (e.g., vascular abnormalities, neoplasms) and underlying disorders of coagulation, platelet function or platelet count (e.g. abnormal coagulation parameters, hemophilia, Von Willebrand's disease, liver disease).
7. History of deep brain stimulator surgery other than sham surgery for participation in a deep brain stimulation clinical trial.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NIO752

NIO752 solution

placebo comparator: Placebo

Placebo in solution

Interventions

NIO752

Solution of antisense oligonucleotide.

Placebo

Placebo solution

Primary outcome measure

  • Change from baseline in the mPSPRS-10 score [ Time Frame: Baseline, Week 72 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Principal Investigator:

Erika D Driver-Dunckley

Univ of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

Principal Investigator:

Lawren Vandevrede

CenExcel Rocky Mtn Clin Research

Recruiting

Englewood, Colorado, United States, 80113

Contacts

Principal Investigator:

Meagen Salinas

Mayo Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Zbigniew K Wszolek

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

James Bower

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Progressive Supranuclear Palsy (PSP)
  • NIO752
  • Anti-Sense Oligonucleotide (ASO)
  • Microtubule Associated Protein Tau (MAPT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-29.