Trial Outcomes & Findings for Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT03654755)

Last Updated: 2023-09-18

Results Overview

The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. Due to early termination of the study, all efficacy analyses were descriptive in nature

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

162 participants

Primary outcome timeframe

3 Months

Results posted on

2023-09-18

Participant Flow

Participants from ASN002AD-101 and ASN002AD-201 were eligible to enter the OLE study if they (1) had participated in ASN002AD-101 study OR (2) had participated in ASN002AD 201 study, had completed at least the first 4 weeks without the use of prohibited treatments for AD, and had completed the study visits up to Week 12. Participants who had received the placebo in the other preceding studies were allowed to be enrolled in the OLE study except those who were responders at Week 12 based on EASI75

Those participants that received placebo in ASN002AD-201 or were enrolled in ASN002-101 were allocated as starting treatment, and those that received ASN002 in ASN002AD-201 trial are allocated as continuing treatment.

Participant milestones

Participant milestones
Measure	ASN002 40 mg ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Overall Study STARTED	45	41	76
Overall Study New Start of Treatment	9	12	15
Overall Study Continued Treatment	36	29	61
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	45	41	76

Reasons for withdrawal

Reasons for withdrawal
Measure	ASN002 40 mg ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Overall Study Early Termination of study due to COVID-19	42	33	56
Overall Study Withdrawal by Subject	2	4	8
Overall Study Lost to Follow-up	1	3	7
Overall Study Physician Decision	0	1	0
Overall Study Adverse Event	0	0	4
Overall Study Lack of Efficacy	0	0	1

Baseline Characteristics

Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ASN002 40 mg n=45 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=41 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=76 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants	143 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 18.34 • n=5 Participants	42.3 years STANDARD_DEVIATION 17.15 • n=7 Participants	42.9 years STANDARD_DEVIATION 15.9 • n=5 Participants	42.4 years STANDARD_DEVIATION 16.82 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants	84 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants	78 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants	120 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study.

Outcome measures

Outcome measures
Measure	ASN002 40 mg n=22 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=18 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=42 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Change From Baseline in Eczema Area Severity Index (EASI) Score	-22.88 Change in score on a scale Standard Deviation 12.914	-18.07 Change in score on a scale Standard Deviation 7.687	-17.38 Change in score on a scale Standard Deviation 13.561

SECONDARY outcome

Timeframe: 3 months

The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The IGA is selected using descriptors that best describe the overall appearance of the lesions at any given point. Signs like inflammation, redness, oozing, and crusting are evaluated. The 0 is the least severe and 4 is the most severe. Due to early termination of the study, all efficacy analyses were descriptive in nature.

Outcome measures

Outcome measures
Measure	ASN002 40 mg n=22 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=18 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=43 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (1)	8 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 3 months

The 5-D Pruritus Scale is a validated questionnaire used in clinical trials to assess the degree, duration, direction, disability, and distribution of the itch to rate the their symptoms over the preceding 2-week period. Each symptoms is scored on a scale of 1 to 5, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst). Due to early termination of the study, all efficacy analyses were descriptive in nature

Outcome measures

Outcome measures
Measure	ASN002 40 mg n=22 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=18 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=43 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Change From Baseline in 5-D Pruritus (Itch) Scale	-7.7 change in score on a scale Standard Deviation 4.21	-7.1 change in score on a scale Standard Deviation 4.93	-6.9 change in score on a scale Standard Deviation 4.97

SECONDARY outcome

Timeframe: 3 months

Intensity of itch will be measured using an NRS to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable" Due to early termination of the study, all efficacy analyses were descriptive in nature

Outcome measures

Outcome measures
Measure	ASN002 40 mg n=19 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=18 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=40 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS)	-3.4 change in score on a scale Standard Deviation 2.99	-3.3 change in score on a scale Standard Deviation 2.93	-3.2 change in score on a scale Standard Deviation 3.16

SECONDARY outcome

Timeframe: 3 months

POEM developed by Charman et al. is a self-assessment of disease severity by the participant. The POEM includes 7 questions to evaluate the number of days the signs and symptoms of eczema over the last week. The answer to each question is categorized by the frequency of the sign or symptom from no days to 7 days. Each question is scored from 0 to 4 and the sum of the questions if the POEM score. The score ranges from 0 to 28 with 0 being the least frequency and 28 showing that all the signs and symptoms occur every day. Therefore, the higher the score, the more severe the eczema. Due to early termination of the study, all efficacy analyses were descriptive in nature

Outcome measures

Outcome measures
Measure	ASN002 40 mg n=22 Participants ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 60 mg n=18 Participants ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks	ASN002 80 mg n=42 Participants ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks
Change From Baseline in Patient-Oriented Eczema Measure (POEM)	-11.0 change in score on a scale Standard Deviation 7.04	-11.5 change in score on a scale Standard Deviation 8.73	-8.7 change in score on a scale Standard Deviation 8.08

Adverse Events

ASN002 40 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

ASN002 60 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ASN002 80 mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ASN002 40 mg n=45 participants at risk ASN002 40 mg Daily dose of ASN002	ASN002 60 mg n=41 participants at risk ASN002 60 mg Daily dose of ASN002	ASN002 80 mg n=76 participants at risk ASN002 80 mg Daily dose of ASN002
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/45 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	0.00% 0/41 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	1.3% 1/76 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days

Other adverse events

Other adverse events
Measure	ASN002 40 mg n=45 participants at risk ASN002 40 mg Daily dose of ASN002	ASN002 60 mg n=41 participants at risk ASN002 60 mg Daily dose of ASN002	ASN002 80 mg n=76 participants at risk ASN002 80 mg Daily dose of ASN002
Infections and infestations Nasopharyngitis	2.2% 1/45 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	7.3% 3/41 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	2.6% 2/76 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days
Infections and infestations Urinary tract infection	2.2% 1/45 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	0.00% 0/41 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days	5.3% 4/76 • Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days

Additional Information

Niranjan Rao

Libertas BioSciences

Phone: 908-872-1133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place