Trial Outcomes & Findings for ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease (NCT NCT04488419)
NCT ID: NCT04488419
Last Updated: 2025-04-04
Results Overview
The Global Statistical Test (GST) score is a composite of cognition and function, calculated as the average of two change from baseline z-scores; the z-scores are calculated for the change from baseline scores for cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\]; lower value indicates improvement) and function (Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version \[ADCS-ADL23\] score; higher value indicates improvement). GST is a standardized score relative to the population mean. Therefore, a GST score of 0 is representative of the population mean. Since GST is a composite of two endpoints, a negative ADCS-ADL23 score is used in deriving GST. Therefore, a lower score indicates improvement, and a higher score indicates worsening. There are no defined clinically relevant thresholds for this GST score.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
554 participants
Primary outcome timeframe
Baseline and Week 26
Results posted on
2025-04-04
Participant Flow
The study was conducted in the United States.
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the clinical efficacy of ATH-1017 treatment compared with placebo in participants with a clinical diagnosis of mild to moderate Alzheimer's disease (AD).
Participant milestones
| Measure |
Placebo
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Safety Population, >=1 Dose Administered
STARTED
|
218
|
224
|
107
|
|
Safety Population, >=1 Dose Administered
COMPLETED
|
183
|
174
|
69
|
|
Safety Population, >=1 Dose Administered
NOT COMPLETED
|
35
|
50
|
38
|
|
Primary Analysis Population
STARTED
|
144
|
143
|
0
|
|
Primary Analysis Population
COMPLETED
|
128
|
122
|
0
|
|
Primary Analysis Population
NOT COMPLETED
|
16
|
21
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Safety Population, >=1 Dose Administered
Adverse Event
|
10
|
22
|
18
|
|
Safety Population, >=1 Dose Administered
Withdrawal by Subject
|
3
|
6
|
1
|
|
Safety Population, >=1 Dose Administered
Lost to Follow-up
|
0
|
3
|
2
|
|
Safety Population, >=1 Dose Administered
Protocol Violation
|
2
|
1
|
0
|
|
Safety Population, >=1 Dose Administered
Lack of Efficacy
|
1
|
1
|
0
|
|
Safety Population, >=1 Dose Administered
Physician Decision
|
0
|
1
|
0
|
|
Safety Population, >=1 Dose Administered
Undetermined
|
15
|
9
|
5
|
|
Safety Population, >=1 Dose Administered
>1 Reason
|
4
|
7
|
12
|
|
Primary Analysis Population
Adverse Event
|
6
|
9
|
0
|
|
Primary Analysis Population
Withdrawal by Subject
|
0
|
4
|
0
|
|
Primary Analysis Population
Protocol Violation
|
1
|
1
|
0
|
|
Primary Analysis Population
Undetermined
|
7
|
3
|
0
|
|
Primary Analysis Population
>1 Reason
|
2
|
4
|
0
|
Baseline Characteristics
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=218 Participants
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
n=224 Participants
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=107 Participants
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
Total
n=549 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
72.7 years
STANDARD_DEVIATION 7.24 • n=7 Participants
|
71.0 years
STANDARD_DEVIATION 6.80 • n=5 Participants
|
72.6 years
STANDARD_DEVIATION 7.19 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
287 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
179 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
457 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
185 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
476 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26Population: Primary Analysis Population (Placebo or 40 mg ATH-1017 mITT Participants not taking AChEIs)
The Global Statistical Test (GST) score is a composite of cognition and function, calculated as the average of two change from baseline z-scores; the z-scores are calculated for the change from baseline scores for cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\]; lower value indicates improvement) and function (Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version \[ADCS-ADL23\] score; higher value indicates improvement). GST is a standardized score relative to the population mean. Therefore, a GST score of 0 is representative of the population mean. Since GST is a composite of two endpoints, a negative ADCS-ADL23 score is used in deriving GST. Therefore, a lower score indicates improvement, and a higher score indicates worsening. There are no defined clinically relevant thresholds for this GST score.
Outcome measures
| Measure |
Placebo
n=144 Participants
Daily subcutaneous (SC) injection of Placebo
Placebo: Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
|
ATH-1017 40 Milligrams (mg)
n=143 Participants
Daily subcutaneous (SC) injection of 40mg ATH-1017
ATH-1017: Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
|
|---|---|---|
|
Global Statistical Test (GST) Score
|
-0.126 Z-score
Standard Error 0.0683
|
-0.208 Z-score
Standard Error 0.0707
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Primary Analysis Population (Placebo or 40 mg ATH-1017 mITT Participants not taking AChEIs)
The ADAS-Cog11 was designed to measure cognitive symptom change in participants with Alzheimer's Disease (AD) and consisted of 11 tasks. The standard 11 items (and corresponding score range) were: word recall (0-10), commands (0-5), constructional praxis (0-5), naming objects and fingers (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), spoken language ability (0-5), comprehension of spoken language (0-5), word-finding difficulty (0-5), and remembering test instructions (0-5). The test included 7 performance items and 4 clinician-rated items. The ADAS-Cog11 total score was the sum of all 11 individual items, with a total score ranging from 0 (no impairment) to 70 (severe impairment). Higher scores indicated more severe cognitive impairment. Baseline was defined as Day 1.
Outcome measures
| Measure |
Placebo
n=144 Participants
Daily subcutaneous (SC) injection of Placebo
Placebo: Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
|
ATH-1017 40 Milligrams (mg)
n=143 Participants
Daily subcutaneous (SC) injection of 40mg ATH-1017
ATH-1017: Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) Change From Baseline
|
-0.39 score on a scale
Standard Error 0.54
|
-1.09 score on a scale
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Primary Analysis Population (Placebo or 40 mg ATH-1017 mITT Participants not taking AChEIs)
The ADCS-ADL23 is a 23-item assessment of functional impairment in terms of activities of daily living administered to the support person/caregiver. It comprises 23 questions about the subject's involvement and level of performance across items representing daily living. The questions range from basic to instrumental activities of daily living. Each item is rated from the highest level of independent performance to complete loss. The total score range is from 0 to 78, with lower scores indicating greater functional impairment. Baseline was defined as Day 1.
Outcome measures
| Measure |
Placebo
n=144 Participants
Daily subcutaneous (SC) injection of Placebo
Placebo: Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
|
ATH-1017 40 Milligrams (mg)
n=143 Participants
Daily subcutaneous (SC) injection of 40mg ATH-1017
ATH-1017: Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-Item Version (ADCS-ADL23) Change From Baseline
|
-0.02 score on a scale
Standard Error 0.65
|
0.65 score on a scale
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Primary Analysis Population (Placebo or 40 mg ATH-1017 mITT Participants not taking AChEIs)
Neurofilament light chain (NfL) is an objective biomarker of neurodegeneration and was measured to quantitatively support the evaluation of ATH-1017. Higher concentrations of NfL in plasma are associated with neurodegeneration.
Outcome measures
| Measure |
Placebo
n=144 Participants
Daily subcutaneous (SC) injection of Placebo
Placebo: Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
|
ATH-1017 40 Milligrams (mg)
n=143 Participants
Daily subcutaneous (SC) injection of 40mg ATH-1017
ATH-1017: Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
|
|---|---|---|
|
Plasma Neurofilament Light Chain (NfL) Concentrations Change From Baseline
|
2.95 picogram / milliter
Standard Error 2.49
|
-0.96 picogram / milliter
Standard Error 2.48
|
Adverse Events
Placebo
Serious events: 15 serious events
Other events: 65 other events
Deaths: 0 deaths
ATH-1017 40 Milligrams (mg)
Serious events: 11 serious events
Other events: 185 other events
Deaths: 0 deaths
ATH-1017 70 mg
Serious events: 3 serious events
Other events: 104 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=218 participants at risk
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
n=224 participants at risk
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=107 participants at risk
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
Cardiac disorders
Atrioventricular block second degree
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.93%
1/107 • Up to 30 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.46%
1/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
1/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Diverticulitis
|
0.46%
1/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
COVID-19
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Cystitis
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Eye infection
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.4%
3/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Infections and infestations
Urosepsis
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Injury, poisoning and procedural complications
Traumatic arthropathy
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.46%
1/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Nervous system disorders
Syncope
|
0.46%
1/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.93%
1/107 • Up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.92%
2/218 • Up to 30 weeks
|
0.00%
0/224 • Up to 30 weeks
|
0.00%
0/107 • Up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/218 • Up to 30 weeks
|
0.45%
1/224 • Up to 30 weeks
|
0.93%
1/107 • Up to 30 weeks
|
Other adverse events
| Measure |
Placebo
n=218 participants at risk
Participants were randomized to receive placebo via subcutaneous (SC) injection once-daily (QD) preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 40 Milligrams (mg)
n=224 participants at risk
Participants were randomized to receive ATH-1017 40 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
ATH-1017 70 mg
n=107 participants at risk
Participants were randomized to receive ATH-1017 70 mg via SC injection QD preferably during daytime. The first SC injection of study drug was performed at site under supervision. The participant should withhold study drug administration on the day of subsequent clinic visits; study drug administration was done on site under supervision of site staff at these visits. Clinic visits took place on Day 1 and thereafter at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit scheduled 4 weeks after completion of the double-blind period at Week 30
|
|---|---|---|---|
|
General disorders
Injection site reactions
|
14.2%
31/218 • Up to 30 weeks
|
57.1%
128/224 • Up to 30 weeks
|
72.9%
78/107 • Up to 30 weeks
|
|
Infections and infestations
COVID-19
|
5.5%
12/218 • Up to 30 weeks
|
4.5%
10/224 • Up to 30 weeks
|
1.9%
2/107 • Up to 30 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.1%
9/218 • Up to 30 weeks
|
2.2%
5/224 • Up to 30 weeks
|
1.9%
2/107 • Up to 30 weeks
|
|
Nervous system disorders
Headache
|
4.1%
9/218 • Up to 30 weeks
|
2.7%
6/224 • Up to 30 weeks
|
2.8%
3/107 • Up to 30 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
9/218 • Up to 30 weeks
|
4.5%
10/224 • Up to 30 weeks
|
4.7%
5/107 • Up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.8%
4/218 • Up to 30 weeks
|
4.5%
10/224 • Up to 30 weeks
|
5.6%
6/107 • Up to 30 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/218 • Up to 30 weeks
|
7.1%
16/224 • Up to 30 weeks
|
7.5%
8/107 • Up to 30 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER