Trial Outcomes & Findings for A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis (NCT NCT05265728)

NCT ID: NCT05265728

Last Updated: 2025-11-25

Results Overview

New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 21 participants
• Primary outcome timeframe: Up to Week 24
• Results posted on: 2025-11-25

Participant Flow

Participants were enrolled at multiple investigative sites in Japan from 26 April 2022 to 29 June 2023.

Participant milestones

Measure	Natalizumab Participants received natalizumab 300 milligrams (mg), subcutaneous (SC), every 4 weeks (Q4W) for 48 weeks.
Overall Study STARTED	21
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Natalizumab Participants received natalizumab 300 milligrams (mg), subcutaneous (SC), every 4 weeks (Q4W) for 48 weeks.
Overall Study Adverse Event	1
Overall Study Study Terminated by Sponsor	5
Overall Study Withdrawal by Subject	2

Baseline Characteristics

A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis

Baseline characteristics by cohort

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Age, Continuous	36.6 years STANDARD_DEVIATION 11.63 • n=45 Participants
Sex: Female, Male Female	14 Participants n=45 Participants
Sex: Female, Male Male	7 Participants n=45 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=45 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=45 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	21 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants
Race (NIH/OMB) White	0 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

New active lesions were defined as the sum of gadolinium (Gd)-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 24 weeks.

Outcome measures

Measure	Natalizumab n=19 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Part 1: Cumulative Number of New Active Lesions up to Week 24 Identified Using Brain Magnetic Resonance Imaging (MRI) Scans	0.4 number of lesions Standard Deviation 0.60

SECONDARY outcome

Timeframe: Up to Week 48

Population: Week 48 analysis set included all participants in the FAS but excluded participants who withdrew from study due to termination of the study by Sponsor. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

New active lesions were defined as the sum of Gd-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions over a period of 48 weeks.

Outcome measures

Measure	Natalizumab n=13 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Part 2: Cumulative Number of New Active Lesions up to Week 48 Identified Using Brain MRI Scans	3.1 number of lesions Standard Deviation 8.47

SECONDARY outcome

Timeframe: At Week 24

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

New active lesions were defined as the sum of gadolinium-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions.

Outcome measures

Measure	Natalizumab n=20 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Part 1: Proportion of Participants With Any New Active Lesions at Week 24 Identified Using Brain MRI Scans	0.05 proportion of participants

SECONDARY outcome

Timeframe: At Week 48

Population: Week 48 analysis set included all participants in the full analysis set but excluded participants who withdrew from study due to termination of the study by Sponsor. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

New active lesions were defined as the sum of Gd-enhancing lesions and non-enhancing new or newly enlarging T2 hyperintense lesions.

Outcome measures

Measure	Natalizumab n=13 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Part 2: Proportion of Participants With Any New Active Lesions at Week 48 Identified Using Brain MRI Scans	0.15 proportion of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 48

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here, 'number analyzed' signifies the number of participants available for analysis at specified time point.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48 Baseline	0.5 number of lesions Standard Deviation 1.44
Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48 Change at Week 24	-0.6 number of lesions Standard Deviation 1.47
Change From Baseline in Number of Gd-Enhancing Lesions at Week 24 and Week 48 Change at Week 48	-0.7 number of lesions Standard Deviation 1.72

SECONDARY outcome

Timeframe: At Week 24

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

Outcome measures

Measure	Natalizumab n=20 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 24	0.3 number of lesions Standard Deviation 1.34

SECONDARY outcome

Timeframe: At Week 48

Population: Week 48 analysis set included all participants in the full analysis set but excluded participants who withdrew from study due to termination of the study by Sponsor. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

Outcome measures

Measure	Natalizumab n=13 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Number of Non-enhancing New or Newly Enlarging T2 Hyperintense Lesions at Week 48	2.1 number of lesions Standard Deviation 6.64

SECONDARY outcome

Timeframe: At Week 24

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

Outcome measures

Measure	Natalizumab n=20 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Number of New T1 Hypointense Lesions at Week 24	0.0 number of lesions Standard Deviation 0.0

SECONDARY outcome

Timeframe: At Week 48

Population: Week 48 analysis set included all participants in the full analysis set but excluded participants who withdrew from study due to termination of the study by Sponsor. Here, 'overall number of participants analyzed' signifies the number of participants available for outcome measure analysis.

Outcome measures

Measure	Natalizumab n=13 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Number of New T1 Hypointense Lesions at Week 48	0.2 number of lesions Standard Deviation 0.60

SECONDARY outcome

Timeframe: At Week 24, Week 48 and Week 52

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment.

ARR is calculated as the total number of relapses that occurred during the treatment period divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52 Week 24	0.508 relapses per participant-year Interval 0.129 to 2.005
Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52 Week 48	0.462 relapses per participant-year Interval 0.087 to 2.457
Annualized Relapse Rate (ARR) at Week 24, Week 48 and Week 52 Week 52	0.456 relapses per participant-year Interval 0.083 to 2.506

SECONDARY outcome

Timeframe: At Week 24 and Week 52

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment.

A multiple sclerosis (MS) relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Proportion of Relapse-Free Participants at Week 24 and Week 52 Week 24	0.8521 proportion of participants
Proportion of Relapse-Free Participants at Week 24 and Week 52 Week 52	0.8521 proportion of participants

SECONDARY outcome

Timeframe: At Week 24 and Week 48

Population: FAS included all participants who had received at least 1 study treatment injection and had at least 1 post baseline efficacy assessment. Here 'number analyzed' signifies the number of participants available for analysis at a specified time point.

The participant's global impression of his/her well-being was assessed with a VAS. The instrument ranges from 0 to 100 millimeters (mm), where a score of 0 denotes 'poor' and a score of 100 denotes 'excellent'. Higher scores indicates a better health state.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Visual Analog Scale (VAS) Score at Week 24 and Week 48 Week 24	71.0 mm Standard Deviation 22.35
Visual Analog Scale (VAS) Score at Week 24 and Week 48 Week 48	61.5 mm Standard Deviation 22.02

SECONDARY outcome

Timeframe: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)

Population: Safety analysis set included all participants who had received at least 1 study treatment injection.

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any AE that has an onset date and time that is on or after the date and time of the first dose of study treatment, or that has worsened after the date and time of the first dose of study treatment through 84 days after the last dose of study treatment.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs TEAEs	95.2 percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Serious TEAEs	4.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Safety analysis set included all participants who had received at least 1 study treatment injection.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Percentage of Participants With Positive Anti-John Cunningham Virus (Anti-JCV) Antibodies	57.1 percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug through 84 days after the last dose of study drug (up to Week 60)

Population: Safety analysis set included all participants who had received at least 1 study treatment injection.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Number of Participants With Injection Site Reactions and Injection Reactions Injection Site Reactions	3 Participants
Number of Participants With Injection Site Reactions and Injection Reactions Injection Reactions	2 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: Immunogenicity analysis set included all participants who had received at least 1 study treatment injection and had at least 1 postbaseline assessment for the specific parameter.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Percentage of Participants With Positive Anti-Natalizumab Antibodies	4.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24 and Week 48

Population: Safety analysis set included all participants who had received at least 1 study treatment injection. Here 'number analyzed' signifies the number of participants available for analysis at a specified time point.

The EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory and cerebral functions, as well as walking ability. It measures the MS disability status on a scale ranging from 0 (normal) to 10 (death due to MS), with higher scores indicating more disability. A negative change from baseline indicates an improvement in the disability.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48 Baseline	1.83 score on a scale Standard Deviation 1.544
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48 Change at Week 24	0.02 score on a scale Standard Deviation 0.536
Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Week 24 and Week 48 Change at Week 48	-0.13 score on a scale Standard Deviation 0.352

SECONDARY outcome

Timeframe: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Population: Pharmacokinetic (PK) analysis set included all participants who had received at least 1 study treatment injection and had at least 1 measurable serum natalizumab concentration. Here 'number analyzed' signifies the number of participants available for analysis at a specified time point.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Serum Trough Concentration (Ctrough) of Natalizumab Baseline	0.0 milligrams per liter (mg/L) Standard Deviation 0.00
Serum Trough Concentration (Ctrough) of Natalizumab Week 4	10.6 milligrams per liter (mg/L) Standard Deviation 6.59
Serum Trough Concentration (Ctrough) of Natalizumab Week 8	15.1 milligrams per liter (mg/L) Standard Deviation 10.11
Serum Trough Concentration (Ctrough) of Natalizumab Week 12	18.3 milligrams per liter (mg/L) Standard Deviation 13.22
Serum Trough Concentration (Ctrough) of Natalizumab Week 16	21.1 milligrams per liter (mg/L) Standard Deviation 16.12
Serum Trough Concentration (Ctrough) of Natalizumab Week 20	20.7 milligrams per liter (mg/L) Standard Deviation 15.13
Serum Trough Concentration (Ctrough) of Natalizumab Week 24	23.6 milligrams per liter (mg/L) Standard Deviation 17.77
Serum Trough Concentration (Ctrough) of Natalizumab Week 28	22.2 milligrams per liter (mg/L) Standard Deviation 14.01
Serum Trough Concentration (Ctrough) of Natalizumab Week 32	20.0 milligrams per liter (mg/L) Standard Deviation 15.70
Serum Trough Concentration (Ctrough) of Natalizumab Week 36	22.1 milligrams per liter (mg/L) Standard Deviation 13.95
Serum Trough Concentration (Ctrough) of Natalizumab Week 40	19.5 milligrams per liter (mg/L) Standard Deviation 15.31
Serum Trough Concentration (Ctrough) of Natalizumab Week 44	22.5 milligrams per liter (mg/L) Standard Deviation 14.76
Serum Trough Concentration (Ctrough) of Natalizumab Week 48	24.0 milligrams per liter (mg/L) Standard Deviation 19.00

SECONDARY outcome

Timeframe: Between Day 6 and Day 8

Population: PK analysis set included all participants who had received at least 1 study treatment injection and had at least 1 measurable serum natalizumab concentration.

One blood sample was collected between Day 6 and Day 8.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Serum Concentration of Natalizumab Between Day 6 and Day 8	29.8 mg/L Standard Deviation 15.07

SECONDARY outcome

Timeframe: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Population: Pharmacodynamic (PD) analysis set included all participants who had received at least 1 study treatment injection and had at least 1 assessment for α4-integrin saturation, serum soluble vascular cell adhesion molecule-1 (VCAM-1) concentration, and lymphocyte counts with lymphocyte subsets. Here 'number analyzed' signifies the number of participants available for analysis at a specified time point.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Trough Alpha-4 (α4) Integrin Saturation Week 20	87.0 percentage Standard Deviation 17.10
Trough Alpha-4 (α4) Integrin Saturation Week 24	87.1 percentage Standard Deviation 23.59
Trough Alpha-4 (α4) Integrin Saturation Week 28	86.4 percentage Standard Deviation 21.97
Trough Alpha-4 (α4) Integrin Saturation Week 32	87.1 percentage Standard Deviation 26.46
Trough Alpha-4 (α4) Integrin Saturation Week 36	82.6 percentage Standard Deviation 23.93
Trough Alpha-4 (α4) Integrin Saturation Week 40	84.6 percentage Standard Deviation 26.27
Trough Alpha-4 (α4) Integrin Saturation Week 44	83.3 percentage Standard Deviation 25.22
Trough Alpha-4 (α4) Integrin Saturation Week 48	80.1 percentage Standard Deviation 24.98
Trough Alpha-4 (α4) Integrin Saturation Week 12	82.8 percentage Standard Deviation 20.22
Trough Alpha-4 (α4) Integrin Saturation Week 16	87.3 percentage Standard Deviation 19.52
Trough Alpha-4 (α4) Integrin Saturation Baseline	4.9 percentage Standard Deviation 4.99
Trough Alpha-4 (α4) Integrin Saturation Week 4	81.9 percentage Standard Deviation 18.31
Trough Alpha-4 (α4) Integrin Saturation Week 8	82.6 percentage Standard Deviation 20.85

SECONDARY outcome

Timeframe: Pre-dose at Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Population: PD analysis set included all participants who had received at least 1 study treatment of study treatment and had at least 1 assessment for α4-integrin saturation, serum soluble VCAM-1 concentration, and lymphocyte counts with lymphocyte subsets. Here 'number analyzed' signifies the number of participants available for analysis at a specified time point.

Outcome measures

Measure	Natalizumab n=21 Participants Participants received natalizumab 300 mg, SC, Q4W for 48 weeks.
Serum Soluble VCAM-1 Concentrations Baseline	468.9 micrograms per liter (µg/L) Standard Deviation 80.90
Serum Soluble VCAM-1 Concentrations Week 4	237.8 micrograms per liter (µg/L) Standard Deviation 66.29
Serum Soluble VCAM-1 Concentrations Week 8	248.2 micrograms per liter (µg/L) Standard Deviation 86.47
Serum Soluble VCAM-1 Concentrations Week 12	239.8 micrograms per liter (µg/L) Standard Deviation 77.96
Serum Soluble VCAM-1 Concentrations Week 16	231.8 micrograms per liter (µg/L) Standard Deviation 70.76
Serum Soluble VCAM-1 Concentrations Week 20	236.0 micrograms per liter (µg/L) Standard Deviation 71.22
Serum Soluble VCAM-1 Concentrations Week 24	237.4 micrograms per liter (µg/L) Standard Deviation 80.38
Serum Soluble VCAM-1 Concentrations Week 28	229.1 micrograms per liter (µg/L) Standard Deviation 80.47
Serum Soluble VCAM-1 Concentrations Week 32	238.1 micrograms per liter (µg/L) Standard Deviation 86.11
Serum Soluble VCAM-1 Concentrations Week 36	243.1 micrograms per liter (µg/L) Standard Deviation 105.46
Serum Soluble VCAM-1 Concentrations Week 40	235.6 micrograms per liter (µg/L) Standard Deviation 80.59
Serum Soluble VCAM-1 Concentrations Week 44	242.0 micrograms per liter (µg/L) Standard Deviation 72.06
Serum Soluble VCAM-1 Concentrations Week 48	244.1 micrograms per liter (µg/L) Standard Deviation 87.07

Adverse Events

Natalizumab

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Natalizumab n=21 participants at risk Participants received natalizumab 300 mg SC Q4W for 48 weeks.
Infections and infestations Progressive multifocal leukoencephalopathy	4.8% 1/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.

Other adverse events

Measure	Natalizumab n=21 participants at risk Participants received natalizumab 300 mg SC Q4W for 48 weeks.
Gastrointestinal disorders Dental caries	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Gastrointestinal disorders Stomatitis	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
General disorders Injection site reaction	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Hepatobiliary disorders Drug-induced liver injury	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Infections and infestations Covid-19	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Infections and infestations Nasopharyngitis	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Infections and infestations Pharyngitis	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Infections and infestations Upper respiratory tract infection	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Investigations Lymphocyte count increased	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Musculoskeletal and connective tissue disorders Neck pain	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Nervous system disorders Headache	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Nervous system disorders Menstrual headache	9.5% 2/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.
Skin and subcutaneous tissue disorders Pruritus	14.3% 3/21 • Deaths were assessed up to 76 weeks; Adverse Events were assessed up to Week 60 Safety analysis set included all participants who had received at least 1 study treatment injection.

Additional Information

US Biogen Clinical Trial Center

Biogen

Phone: 866-633-4636

Email: clinicaltrials@biogen.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally, the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor's Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of the Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER