Migraine Disorder
Conditions
Brief summary
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
Interventions
BIOLOGICALALD403 (Eptinezumab)
Sponsors
Alder Biopharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
Exclusion criteria
* Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening. * Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome). * Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded. * History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) | 104 Weeks | 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. |
| Number of Participants With a Clinically Significant Electrocardiogram | Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104 | Overall investigator interpretation of participant electrocardiogram |
| Number of Participants With Any Clinically Significant Laboratory Values | 104 Weeks | Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database. |
| Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) | 104 Weeks | 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. |
| Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | 104 Weeks | Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score | Baseline to Week 12 | 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. |
| Patient Global Impression of Change (PGIC) at Week 104 | Week 104 | 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. |
| Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 | 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. |
| Development of Anti-ALD403 Antibody by Visit | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 | 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. |
| Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Baseline to Week 12 | 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. |
| Health Related Quality of Life (EQ-5D-5L) at Week 12 | Week 12 | 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. |
| Change in Baseline of Headache Impact Test (HIT-6) Score | Baseline, Week 1-4, Week 9-12 | 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. |
| Change in Most Bothersome Symptom at Week 48 | Baseline to Week 48 | 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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 158 participants signed the ICF, of which 128 participants met the entry criteria and were randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| 300 mg ALD403 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. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Study Burden | 9 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | 300 mg ALD403 |
|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 11.33 |
| Duration of migraine diagnosis at baseline | 21.2 years STANDARD_DEVIATION 11.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Region of Enrollment United States | 128 participants |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 49 / 128 |
| serious Total, serious adverse events | 5 / 128 |
Outcome results
Primary
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: 104 Weeks
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) | Participants Experiencing Suicidal Ideation | 0 Participants |
| 300 mg ALD403 | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) | Participants Experiencing Suicidal Behavior | 0 Participants |
Primary
Number of Participants With a Clinically Significant Electrocardiogram
Overall investigator interpretation of participant electrocardiogram
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Baseline | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Day 0 Postdose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 12 Predose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 12 Postdose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 24 Predose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 24 Postdose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 36 Predose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 36 Postdose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 48 Predose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 48 Postdose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 60 Predose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 60 Postdose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 72 Predose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 72 Postdose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 84 Predose | 1 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 84 Postdose | 0 Participants |
| 300 mg ALD403 | Number of Participants With a Clinically Significant Electrocardiogram | Week 104 | 1 Participants |
Primary
Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs
Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator
Time frame: 104 Weeks
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | Number of CS changes in diastolic blood pressure | 0 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | Number of CS changes in systolic blood pressure | 0 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | Number of CS changes in heart rate value | 0 Participants |
Primary
Number of Participants With Any Clinically Significant Laboratory Values
Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.
Time frame: 104 Weeks
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hematocrit Decreased | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hemoglobin Decreased | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Blood Glucose Increased | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hypertriglyceridemia | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Blood Potassium Decreased | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hypokalemia | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Blood Mercury Abnormal | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hypercholesterolemia | 1 Participants |
| 300 mg ALD403 | Number of Participants With Any Clinically Significant Laboratory Values | Hyperlipidemia | 1 Participants |
Primary
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: 104 Weeks
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 300 mg ALD403 | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) | 91 Participants |
Secondary
Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score
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.
Time frame: Baseline to Week 12
Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 300 mg ALD403 | Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score | -36.3 score on a scale | Standard Deviation 51.85 |
Secondary
Change in Baseline of Headache Impact Test (HIT-6) Score
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 300 mg ALD403 | Change in Baseline of Headache Impact Test (HIT-6) Score | Week 1-4 | -8.0 score on a scale | Standard Deviation 8.06 |
| 300 mg ALD403 | Change in Baseline of Headache Impact Test (HIT-6) Score | Week 9-12 | -7.9 score on a scale | Standard Deviation 7.96 |
Secondary
Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
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.
Time frame: Baseline to Week 12
Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | 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 |
| 300 mg ALD403 | Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | Vitality | 3.0 score on a scale | Standard Deviation 7.9 |
Secondary
Change in Most Bothersome Symptom at Week 48
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.
Time frame: Baseline to Week 48
Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 48 Visit are included
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Very Much Improved | 40 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Much Improved | 44 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Minimally Improved | 17 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | No Change | 11 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Minimally Worse | 0 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Much Worse | 0 Participants |
| 300 mg ALD403 | Change in Most Bothersome Symptom at Week 48 | Very Much Worse | 0 Participants |
Secondary
Development of Anti-ALD403 Antibody by Visit
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.
Time frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Day 0: ADA Results | ADA Positive | 0 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Day 0: ADA Results | ADA Negative | 128 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 2 : ADA Results | ADA Positive | 1 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 2 : ADA Results | ADA Negative | 126 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 4 : ADA Results | ADA Positive | 0 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 4 : ADA Results | ADA Negative | 126 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 8 : ADA Results | ADA Positive | 7 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 8 : ADA Results | ADA Negative | 118 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 12 : ADA Results | ADA Positive | 11 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 12 : ADA Results | ADA Negative | 112 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 24 : ADA Results | ADA Positive | 21 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 24 : ADA Results | ADA Negative | 99 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 36 : ADA Results | ADA Positive | 9 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 36 : ADA Results | ADA Negative | 109 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 48 : ADA Results | ADA Positive | 6 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 48 : ADA Results | ADA Negative | 107 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 72 : ADA Results | ADA Positive | 4 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 72 : ADA Results | ADA Negative | 97 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 104 : ADA Results | ADA Positive | 0 Participants |
| 300 mg ALD403 | Development of Anti-ALD403 Antibody by Visit | Week 104 : ADA Results | ADA Negative | 96 Participants |
Secondary
Health Related Quality of Life (EQ-5D-5L) at Week 12
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.
Time frame: Week 12
Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | No problems | 110 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Slight problems | 11 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Moderate problems | 3 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Severe problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Mobility | Extreme problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | No problems | 121 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Slight problems | 3 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Moderate problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Severe problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Self-care | Extreme problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | No problems | 95 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Slight problems | 18 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Moderate problems | 11 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Severe problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Usual Activities | Extreme problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | No problems | 55 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Slight problems | 42 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Moderate problems | 22 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Severe problems | 5 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Pain/Discomfort | Extreme problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | No problems | 96 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Slight problems | 22 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Moderate problems | 6 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Severe problems | 0 Participants |
| 300 mg ALD403 | Health Related Quality of Life (EQ-5D-5L) at Week 12 | Anxiety/Depression | Extreme problems | 0 Participants |
Secondary
Patient Global Impression of Change (PGIC) at Week 104
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.
Time frame: Week 104
Population: Safety Population includes all participants who received study drug. Only participants who completed the Week 104 Visit are included
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Very Much Improved | 47 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Much Improved | 33 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Minimally Improved | 11 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | No Change | 5 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Minimally Worse | 0 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Much Worse | 0 Participants |
| 300 mg ALD403 | Patient Global Impression of Change (PGIC) at Week 104 | Very Much Worse | 0 Participants |
Secondary
Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit
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.
Time frame: Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104
Population: Safety Population includes all participants who received study drug.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Day 0: NAb Results | NAb Positive | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Day 0: NAb Results | NAb Negative | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 2 : NAb Results | NAb Positive | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 2 : NAb Results | NAb Negative | 1 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 4 : NAb Results | NAb Positive | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 4 : NAb Results | NAb Negative | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 8 : NAb Results | NAb Positive | 3 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 8 : NAb Results | NAb Negative | 4 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 12 : NAb Results | NAb Positive | 8 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 12 : NAb Results | NAb Negative | 3 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 24 : NAb Results | NAb Positive | 5 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 24 : NAb Results | NAb Negative | 16 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 36 : NAb Results | NAb Positive | 1 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 36 : NAb Results | NAb Negative | 8 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 48 : NAb Results | NAb Positive | 1 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 48 : NAb Results | NAb Negative | 5 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 72 : NAb Results | NAb Positive | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 72 : NAb Results | NAb Negative | 4 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 104 : NAb Results | NAb Positive | 0 Participants |
| 300 mg ALD403 | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Week 104 : NAb Results | NAb Negative | 0 Participants |