A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)

JRCT ID: jRCT2031200333

Registered date:29/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Neuromyelitis Optica Spectrum Disorder (NMOSD)
• Date of first enrollment: 02/03/2021
• Target sample size: 127
• Countries of recruitment: Italy,Japan,Taiwan,Japan,United States,Japan,Poland,Japan,Canada,Japan,United Kingdom,Japan,Ukraine,Japan,Bulgaria,Japan,Turkey,Japan,Korea,Japan,Romania,Japan,Georgia,Japan,Malaysia,Japan,Croatia,Japan,Hungary,Japan,Spain,Japan,Germany,Japan
• Study type: Interventional
• Intervention(s): Satralizumab: 120 mg SC injection every 4 weeks (Q4W)

Outcome(s)

Primary Outcome

Sefety, Efficacy, Pharmacokinetics, Pharmacodynamics
- safety
To evaluate the long-term safety
- efficacy
Time to first relapse (TFR) and proportion of patients who are relapse-free
Annualized relapse rate (ARR)
Change in Expanded Disability Status Scale (EDSS) score
Time to EDSS worsening and proportion of patients without EDSS worsening
Change in visual acuity
- pharmacodynamics
The pharmacodynamics (PD) objective for this study is to further characterize the target engagement in response to satralizumab treatment on the basis of the assessment of IL-6, soluble IL-6R (sIL-6R) and C-reactive protein (CRP)
- pharmacokinetics
Serum concentration of satralizumab at specified timepoints

Secondary Outcome

Safety
To further evaluate the risks of serious infections and hepatotoxicity

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were AQP4-IgG seropositive at screening in
these studies. Patients with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the patient.
2. Signed Informed Consent Form (ICF)
3. Ability to comply with the study protocol
4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mullerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
The following are examples of adequate contraceptive methods: bilateral tubal ligation; male sterilization; hormonal contraceptives; hormone-releasing intrauterine devices; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.

Exclude criteria

1.Use of prohibited medication
2. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug.
3. Evidence of any serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
4. Known active infection that requires delaying the next satralizumab dose at the time of enrollment.
In case of an active infection, the patient should remain in the parent study, as governed by that protocol, and may enroll in this study once the active infection is controlled.
5. NMOSD relapse at the time of enrollment.
In case of a relapse, the patient should remain in the parent study, as governed by that protocol, and may enroll in this study once the patient is stable.
6. Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab (see Section 5.1.1)
If a patient does not meet the criteria to restart treatment with satralizumab based on laboratory assessments, the patient should remain in the parent study and the baseline visit should be delayed. The last assessment before enrollment must meet the re-treatment criteria.

Related Information

• Primary Sponsor: Hans-Christian von Buedingen
• Secondary ID(s): NCT04660539