Trial Outcomes & Findings for A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention (NCT NCT05269667)

Results Overview

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Up to 14 months

Results posted on

2025-01-22

Participant Flow

Participants took part in this study at 3 investigative sites in 3 countries.

A total of 4 participants with neuromyelitis optica spectrum disorder (NMOSD) were enrolled in 'Cohort 2: Inadequate Responders to Previous Rituximab (RTX) Treatment' to receive satralizumab. No participants were enrolled in 'Cohort 1: Treatment-naïve Participants' due to early study termination.

Participant milestones

Participant milestones
Measure	Cohort 2: Inadequate Responders to Previous Rituximab (RTX) Treatment Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 2: Inadequate Responders to Previous Rituximab (RTX) Treatment Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Overall Study Study Terminated by Sponsor	4

Baseline Characteristics

A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Relapse-Free Participants	100 percentage of participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

The ARR was calculated descriptively by dividing the total number of relapses for all participants by the total years of drug exposure. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Annualized Relapse Rate (ARR)	0 relapses per participant-year Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

TFR was defined as the time from first dose of satralizumab to the first occurrence of relapse. Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Time to First Relapse (TFR)	NA weeks Median and 95% Confidence Interval (CI) was not estimable due to no participants with events.

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the occurrence of hospitalization.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Participants Hospitalized Due to Relapse	0 percentage of participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on use of corticosteroids.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Participants Using Corticosteroids Due to Relapse	0 percentage of participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need of rescue therapy. Rescue therapy for clinical relapse included pulse intravenous (IV) corticosteroids, oral corticosteroids for tapering, intravenous immunoglobulin (IVIG) and/or apheresis (including plasma exchange and plasmapheresis).

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Participants in Need of Rescue Therapy Due to Relapse	0 percentage of participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse. The severity of relapses was assessed based on the need for plasma exchange.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Participants in Need of Plasma Exchange Due to Relapse	0 percentage of participants

PRIMARY outcome

Timeframe: Up to 14 months

Population: ITT population included all enrolled participants who received any dose of satralizumab.

Relapse was the occurrence of new or worsening neurological symptoms attributable to NMOSD. New or worsening neurological symptoms that occur \<31 days following the onset of a relapse were considered part of the same relapse.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Percentage of Participants With Residual Disability Due to Relapse	0 percentage of participants

PRIMARY outcome

Timeframe: Up to Week 36

Population: ITT population included all enrolled participants who received any dose of satralizumab.

EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Change From Baseline in Expanded Disability Status Scale (EDSS) Score	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: ITT population included all enrolled participants who received any dose of satralizumab.

EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 12 Weeks	NA weeks Median and 95% CI were not estimable due to no participants with events.

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses.

SDMT testing was to detect impairment of key neurocognitive functions that underlie many substitution tasks, including sustained attention, visual scanning, and recent memory. The test consisted of a sequence of 110 symbols displayed in a maximum 90 seconds and a reference key legend with 9 symbols in a given order and their respective matching digits from 1 to 9. The test measures the speed (number of correct paired responses) to pair abstract symbols with specific digits in 90 seconds time. The score is the number of correctly paired items in 90 seconds with a maximum score of 110 and minimum of 0. Higher scores indicate improvement.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=1 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Change From Baseline in the Symbol Digital Modalities Test (SDMT)	-5 score on a scale Standard Deviation NA The standard deviation (SD) was not estimable as only a single participant was evaluable.

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses.

Best corrected high-contrast (100%) and low-contrast (2.5%) visual acuities were measured at distances of both 4 and 1 meters with the appropriate eye charts. Each eye was tested individually. No visual acuities were obtained with both eyes open. The participants read the charts from left to right starting with the top line (largest letters). The participants proceeded to each lower line until he/she could not see the letters. The total number of letters read correctly were recorded for each eye. Visual acuity was measured before any drops are instilled into the eye and before OCT assessments.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=1 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts Right High Contrast	-14 Letters correct
Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts Left High Contrast	80 Letters correct
Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts Right Low Contrast	60 Letters correct
Change in High Contrast (100%) and Low Contrast (2.5%) Visual Acuity Using High-and Low-contrast Letter Acuity (LCLA) Charts Left Low Contrast	33 Letters correct

PRIMARY outcome

Timeframe: At Week 24

Population: ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses.

The National Eye institute (NEI) VFQ-25 captures a participants's perception of vision-related functioning and vision-related quality of life. The core measures include 25 items that comprise 11 vision-related subscales and one item on general health. The NEI VFQ-25 also included an appendix of additional items that was used to expand the scales up to 39 total items. The composite score and the subscale scores range from 0 to 100, with higher scores indicating better vision-related functioning.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=1 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Change in Visual Functioning Questionnaire -25 (VFQ-25)	10 score on a scale Standard Deviation NA The SD was not estimable as only a single participant was evaluable.

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: ITT population included all enrolled participants who received any dose of satralizumab.

EDSS was a quantitative measure of disability and for assessment of severity of relapse for participants with NMOSD. The overall score ranges from 0 points (normal neurological examination) up to 10 points (death), increasing in increments of 0.5 points. Higher scores represent increased disability. CDP was defined as 1-point or greater worsening in EDSS from baseline that is not attributable to another etiology when the baseline score is 5.5 or less, and ≥ 0.5 when the baseline score is above 5.5. Disability progression was considered confirmed when the increase in the EDSS is confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks	NA weeks Median and 95% CI was not estimable due to no participants with events.

SECONDARY outcome

Timeframe: Weeks 4, 8, 12 and 24

Population: ITT population included all enrolled participants who received any dose of satralizumab.

MRI was used to monitor central nervous system (CNS) lesions and potentially other pathophysiology, such as inflammation and neurodegeneration. LETM=longitudinally extensive transverse myelitis. Stm=subcortical temporal medial. Count of T2-weighted FLAIR hyperintense lesions (including new and enlarging) were distributed across the following regions: cerebrum, optic nerves, optic chiasm, area postrema, brainstem and cerebellum.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=9 lesion Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Baseline: Hyperintense Lesion	3 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 4: Hyperintense Lesion	3 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 8: Hyperintense Lesion	2 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 8: Hyperintense Letm Lesion	1 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 24: Hyperintense Lesion	1 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 12: Hyperintense Lesion	3 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Baseline: Hyperintense Letm Lesion	2 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 4: Hyperintense Letm Lesion	2 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 12: Hyperintense Letm Lesion	1 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Baseline: Hyperintense Stm Lesion	9 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 4: Hyperintense Stm Lesion	8 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 8: Hyperintense Stm Lesion	8 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 12: Hyperintense Stm Lesion	8 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 24: Hyperintense Letm Lesion	0 number of lesions
Count of T2-weighted Fluid-Attenuated Inversion-Recovery (FLAIR) Hyperintense Lesions Assessed Using Magnetic Resonance Imaging (MRI) Scans Week 24: Hyperintense Stm Lesion	1 number of lesions

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all enrolled participants who received any dose of satralizumab. Overall number of participants analyzed is the number of participants with data available for analyses.

MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=1 lesion Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Volume of T2-weighted FLAIR Hyperintense Lesions Assessed Using MRI Scans Baseline	0.2285 milliliter (mL) Standard Deviation NA The SD was not estimable as only a single participant was evaluable.
Volume of T2-weighted FLAIR Hyperintense Lesions Assessed Using MRI Scans Week 12	0.2520 milliliter (mL) Standard Deviation NA The SD was not estimable as only a single participant was evaluable.

SECONDARY outcome

Timeframe: Basline, Weeks 4, and 12

Population: ITT population included all enrolled participants who received any dose of satralizumab.

MRI was used to monitor CNS lesions and potentially other pathophysiology, such as inflammation and neurodegeneration.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Number of Participants With Contrast-enhancing T1-weighted Lesions (CEL) Assessed Using MRI Scans	0 Participants

SECONDARY outcome

Timeframe: Up to 14 months

Population: Safety population included all enrolled participants who received any dose of satralizumab.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. An AESI included drug induced liver injury and suspected transmission of infectious agent via medicinal products.

Outcome measures

Outcome measures
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 Participants Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) SAE	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) AESIs	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) AE	2 Participants

Adverse Events

Cohort 2: Inadequate Responders to Previous RTX Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 2: Inadequate Responders to Previous RTX Treatment n=4 participants at risk Participants with inadequate response to previous RTX treatment received 120 mg of satralizumab monotherapy as SC injection on Day 1 of Weeks 0, 2, 4 and then Q4W up to Week 92.
General disorders Injection site reaction	25.0% 1/4 • Up to 14 months Safety population included all enrolled participants who received any dose of satralizumab.
Investigations Alanine aminotransferase increased	25.0% 1/4 • Up to 14 months Safety population included all enrolled participants who received any dose of satralizumab.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigators are free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER