Trial Outcomes & Findings for An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (NCT NCT02985398)

NCT ID: NCT02985398

Last Updated: 2020-04-21

Results Overview

Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 128 participants
• Primary outcome timeframe: 104 Weeks
• Results posted on: 2020-04-21

Participant Flow

A total of 158 participants signed the ICF, of which 128 participants met the entry criteria and were randomized into the trial.

Participant milestones

Measure	300 mg ALD403 Participants were enrolled and scheduled to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Study STARTED	128
Overall Study Participants Treated	128
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	300 mg ALD403 Participants were enrolled and scheduled to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	8
Overall Study Study Burden	9

Baseline Characteristics

An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine

Baseline characteristics by cohort

Measure	300 mg ALD403 n=128 Participants Participants were randomized to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Age, Continuous	41.5 years STANDARD_DEVIATION 11.33 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 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	1 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	4 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	128 participants n=5 Participants
Duration of migraine diagnosis at baseline	21.2 years STANDARD_DEVIATION 11.65 • n=5 Participants

PRIMARY outcome

Timeframe: 104 Weeks

Population: Safety Population includes all participants who received study drug.

Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)	91 Participants

PRIMARY outcome

Timeframe: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104

Population: Safety Population includes all participants who received study drug.

Overall investigator interpretation of participant electrocardiogram

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Number of Participants With a Clinically Significant Electrocardiogram Baseline	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 12 Postdose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 24 Predose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 24 Postdose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 36 Predose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 36 Postdose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 48 Predose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 48 Postdose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 72 Postdose	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 84 Predose	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 84 Postdose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 104	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Day 0 Postdose	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 12 Predose	0 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 60 Predose	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 60 Postdose	1 Participants
Number of Participants With a Clinically Significant Electrocardiogram Week 72 Predose	1 Participants

PRIMARY outcome

Timeframe: 104 Weeks

Population: Safety Population includes all participants who received study drug.

Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Number of Participants With Any Clinically Significant Laboratory Values Blood Potassium Decreased	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hypokalemia	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Blood Mercury Abnormal	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hypercholesterolemia	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hematocrit Decreased	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hemoglobin Decreased	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Blood Glucose Increased	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hypertriglyceridemia	1 Participants
Number of Participants With Any Clinically Significant Laboratory Values Hyperlipidemia	1 Participants

PRIMARY outcome

Timeframe: 104 Weeks

Population: Safety Population includes all participants who received study drug.

Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) Participants Experiencing Suicidal Ideation	0 Participants
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) Participants Experiencing Suicidal Behavior	0 Participants

PRIMARY outcome

Timeframe: 104 Weeks

Population: Safety Population includes all participants who received study drug.

Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs Number of CS changes in diastolic blood pressure	0 Participants
Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs Number of CS changes in systolic blood pressure	0 Participants
Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs Number of CS changes in heart rate value	0 Participants

SECONDARY outcome

Timeframe: Week 104

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 104 Visit are included

The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.

Outcome measures

Measure	300 mg ALD403 n=96 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Patient Global Impression of Change (PGIC) at Week 104 Very Much Improved	47 Participants
Patient Global Impression of Change (PGIC) at Week 104 Much Improved	33 Participants
Patient Global Impression of Change (PGIC) at Week 104 Minimally Improved	11 Participants
Patient Global Impression of Change (PGIC) at Week 104 No Change	5 Participants
Patient Global Impression of Change (PGIC) at Week 104 Minimally Worse	0 Participants
Patient Global Impression of Change (PGIC) at Week 104 Much Worse	0 Participants
Patient Global Impression of Change (PGIC) at Week 104 Very Much Worse	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included

The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement.

Outcome measures

Measure	300 mg ALD403 n=124 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Mental Health	1.4 score on a scale Standard Deviation 7.86
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Physical Component	4.5 score on a scale Standard Deviation 7.08
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Bodily Pain	5.8 score on a scale Standard Deviation 10.06
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores General Health	1.6 score on a scale Standard Deviation 6.46
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Mental Component	1.9 score on a scale Standard Deviation 7.89
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Physical Functioning	2.9 score on a scale Standard Deviation 6.15
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Role Emotional	2.3 score on a scale Standard Deviation 9.09
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Role Physical	4.8 score on a scale Standard Deviation 8.34
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Social Functioning	4.9 score on a scale Standard Deviation 9.13
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores Vitality	3.0 score on a scale Standard Deviation 7.90

SECONDARY outcome

Timeframe: Week 12

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included

The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.

Outcome measures

Measure	300 mg ALD403 n=124 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Health Related Quality of Life (EQ-5D-5L) at Week 12 Mobility · Severe problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Mobility · Extreme problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Self-care · Extreme problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Pain/Discomfort · No problems	55 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Usual Activities · Severe problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Usual Activities · Extreme problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Pain/Discomfort · Slight problems	42 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Pain/Discomfort · Moderate problems	22 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Pain/Discomfort · Severe problems	5 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Pain/Discomfort · Extreme problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Anxiety/Depression · No problems	96 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Anxiety/Depression · Slight problems	22 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Anxiety/Depression · Moderate problems	6 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Anxiety/Depression · Severe problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Anxiety/Depression · Extreme problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Mobility · No problems	110 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Mobility · Slight problems	11 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Mobility · Moderate problems	3 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Self-care · No problems	121 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Self-care · Slight problems	3 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Self-care · Moderate problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Self-care · Severe problems	0 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Usual Activities · No problems	95 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Usual Activities · Slight problems	18 Participants
Health Related Quality of Life (EQ-5D-5L) at Week 12 Usual Activities · Moderate problems	11 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1-4, Week 9-12

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included

The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Change in Baseline of Headache Impact Test (HIT-6) Score Week 1-4	-8.0 score on a scale Standard Deviation 8.06
Change in Baseline of Headache Impact Test (HIT-6) Score Week 9-12	-7.9 score on a scale Standard Deviation 7.96

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 48 Visit are included

The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale.

Outcome measures

Measure	300 mg ALD403 n=112 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Change in Most Bothersome Symptom at Week 48 Very Much Improved	40 Participants
Change in Most Bothersome Symptom at Week 48 Much Improved	44 Participants
Change in Most Bothersome Symptom at Week 48 Minimally Improved	17 Participants
Change in Most Bothersome Symptom at Week 48 No Change	11 Participants
Change in Most Bothersome Symptom at Week 48 Minimally Worse	0 Participants
Change in Most Bothersome Symptom at Week 48 Much Worse	0 Participants
Change in Most Bothersome Symptom at Week 48 Very Much Worse	0 Participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included

The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability:

0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability;

A higher value represents a worse outcome.

Outcome measures

Measure	300 mg ALD403 n=123 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score	-36.3 score on a scale Standard Deviation 51.85

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104

Population: Safety Population includes all participants who received study drug.

Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Development of Anti-ALD403 Antibody by Visit Week 2 : ADA Results · ADA Positive	1 Participants
Development of Anti-ALD403 Antibody by Visit Week 4 : ADA Results · ADA Negative	126 Participants
Development of Anti-ALD403 Antibody by Visit Week 8 : ADA Results · ADA Negative	118 Participants
Development of Anti-ALD403 Antibody by Visit Week 12 : ADA Results · ADA Positive	11 Participants
Development of Anti-ALD403 Antibody by Visit Day 0: ADA Results · ADA Positive	0 Participants
Development of Anti-ALD403 Antibody by Visit Day 0: ADA Results · ADA Negative	128 Participants
Development of Anti-ALD403 Antibody by Visit Week 2 : ADA Results · ADA Negative	126 Participants
Development of Anti-ALD403 Antibody by Visit Week 4 : ADA Results · ADA Positive	0 Participants
Development of Anti-ALD403 Antibody by Visit Week 8 : ADA Results · ADA Positive	7 Participants
Development of Anti-ALD403 Antibody by Visit Week 12 : ADA Results · ADA Negative	112 Participants
Development of Anti-ALD403 Antibody by Visit Week 24 : ADA Results · ADA Positive	21 Participants
Development of Anti-ALD403 Antibody by Visit Week 24 : ADA Results · ADA Negative	99 Participants
Development of Anti-ALD403 Antibody by Visit Week 36 : ADA Results · ADA Positive	9 Participants
Development of Anti-ALD403 Antibody by Visit Week 36 : ADA Results · ADA Negative	109 Participants
Development of Anti-ALD403 Antibody by Visit Week 48 : ADA Results · ADA Positive	6 Participants
Development of Anti-ALD403 Antibody by Visit Week 48 : ADA Results · ADA Negative	107 Participants
Development of Anti-ALD403 Antibody by Visit Week 72 : ADA Results · ADA Positive	4 Participants
Development of Anti-ALD403 Antibody by Visit Week 72 : ADA Results · ADA Negative	97 Participants
Development of Anti-ALD403 Antibody by Visit Week 104 : ADA Results · ADA Positive	0 Participants
Development of Anti-ALD403 Antibody by Visit Week 104 : ADA Results · ADA Negative	96 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104

Population: Safety Population includes all participants who received study drug.

Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity.

Outcome measures

Measure	300 mg ALD403 n=128 Participants Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 8 : NAb Results · NAb Negative	4 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 12 : NAb Results · NAb Positive	8 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 36 : NAb Results · NAb Positive	1 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 36 : NAb Results · NAb Negative	8 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 48 : NAb Results · NAb Positive	1 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 48 : NAb Results · NAb Negative	5 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 72 : NAb Results · NAb Positive	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 72 : NAb Results · NAb Negative	4 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Day 0: NAb Results · NAb Positive	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Day 0: NAb Results · NAb Negative	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 2 : NAb Results · NAb Positive	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 2 : NAb Results · NAb Negative	1 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 4 : NAb Results · NAb Positive	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 4 : NAb Results · NAb Negative	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 8 : NAb Results · NAb Positive	3 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 12 : NAb Results · NAb Negative	3 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 24 : NAb Results · NAb Positive	5 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 24 : NAb Results · NAb Negative	16 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 104 : NAb Results · NAb Positive	0 Participants
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit Week 104 : NAb Results · NAb Negative	0 Participants

Adverse Events

300 mg ALD403

Serious events: 5 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	300 mg ALD403 n=128 participants at risk Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Immune system disorders Anaphylactic Reaction	0.78% 1/128 • Baseline to Week 104 (end of study)
Infections and infestations Pneumonia	0.78% 1/128 • Baseline to Week 104 (end of study)
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.78% 1/128 • Baseline to Week 104 (end of study)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 1/128 • Baseline to Week 104 (end of study)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.78% 1/128 • Baseline to Week 104 (end of study)
Psychiatric disorders Conversion Disorder	0.78% 1/128 • Baseline to Week 104 (end of study)

Other adverse events

Measure	300 mg ALD403 n=128 participants at risk Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84.
Infections and infestations Bronchitis	5.5% 7/128 • Baseline to Week 104 (end of study)
Infections and infestations Influenza	6.2% 8/128 • Baseline to Week 104 (end of study)
Infections and infestations Nasopharyngitis	14.1% 18/128 • Baseline to Week 104 (end of study)
Infections and infestations Sinusitis	7.8% 10/128 • Baseline to Week 104 (end of study)
Infections and infestations Upper respiratory tract infection	7.8% 10/128 • Baseline to Week 104 (end of study)
Nervous system disorders Migraine	5.5% 7/128 • Baseline to Week 104 (end of study)

Additional Information

Email contact via

H. Lundbeck A/S

Phone: +4536301311

Email: LundbeckClinicalTrials@Lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place