Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02658916
• Date of registration: 13/01/2016
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003
• Scientific title: A Multicenter, Open-Label, Long-Term Treatment Study of Intravenously Administered BIIB092 in Patients With Progressive Supranuclear Palsy Who Participated in Study CN002003
• Date of first enrolment: February 22, 2016
• Target sample size: 47
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02658916
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

1. Completed treatment in Study CN002003.

2. A diagnosis of probable or possible PSP consistent with Study CN002003 criteria with
no new medical information or diagnoses since enrollment into Study CN002003 that
might confer doubt on the PSP diagnosis.

3. Able to tolerate Magnetic Resonance Imaging (MRI).

4. Able to perform all protocol-specified assessments and comply with the study visit
schedule.

5. Have reliable caregiver to accompany patient to all study visits. Caregiver must be
able to read, understand, and speak local language fluently to ensure comprehension of
informed consent and informant-based assessments of patient. Caregiver must also have
frequent contact with patient (at least 3 hours per week at one time or at different
times) and be willing to monitor the patient's health and concomitant medications
throughout the study.

6. Patient must reside outside a skilled nursing facility or dementia care facility at
the time of enrollment

7. Women of childbearing potential (WOCBP) and sexually active fertile men with partners
who are WOCBP must use highly effective birth control.

Key Exclusion Criteria:

1. Presence of an unstable, clinically significant medical condition other than PSP
including, but not limited to: hematological, endocrine, cardiovascular, renal,
hepatic, gastrointestinal, immunological, psychological or neurological disease or
malignancy.

2. Contraindication to undergoing a lumbar puncture (LP).

3. Recent drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental
Disorders (4th Edition).

4. Treatment with any investigational drugs (including placebo) other than BIIB092 or
placebo given in Study CN002003 or devices within 90 days prior to enrollment

5. Any vaccination within 30 days prior to study drug administration.

6. Contraindication to the MRI examination for any reason

7. Any other sound medical, psychiatric, and/or social reason as determined by the
investigator

8. Known history of human immunodeficiency virus.

9. Evidence of organ dysfunction or significant deterioration from prior values in
CN002003 beyond what is consistent with the target population or that would place the
patient at increased risk or risk of early study discontinuation.

10. Inability to be venipunctured and/or tolerate venous access.

11. History of allergy, hypersensitivity, or serious adverse reaction to monoclonal
antibodies or related compounds or allergy to any of the components of the study drug

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply



Age minimum: 41 Years
Age maximum: 86 Years
Gender: All

Health Condition(s) or Problem(s) studied

Supranuclear Palsy, Progressive

Intervention(s)

Drug: BIIB092

Primary Outcome(s)

Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Deaths [Time Frame: Day 1 through study completion (approximately 1.5 years or later)]

Percentage of Participants with Marked Abnormalities in Clinical Laboratory Tests, Vital sign Measurements, ECGs, and Physical and Neurological Examinations [Time Frame: Day 1 through study completion (approximately 1.5 years or later)]

Secondary Outcome(s)

End-of-Infusion Serum Concentration of BIIB092 [Time Frame: Day 1 through study completion (approximately 1.5 years or later)]

Serum Trough Concentration (C-trough) of BIIB092 [Time Frame: Up to study completion (approximately 1.5 years or later)]

Number of Participants with drug antibodies (anti-BIIB092) in Serum [Time Frame: Up to study completion (approximately 1.5 years or later)]

Percent Change from Baseline in Cerebrospinal Fluid (CSF) Concentrations of unbound N-terminal Tau at Week 48 [Time Frame: Baseline, Week 48]

Secondary ID(s)

CN002-004

251PP201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors