Trial Outcomes & Findings for POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis (NCT NCT05932654)

Results Overview

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Week 26

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	300 mg BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Overall Study STARTED	22
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	300 mg n=22 Participants BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43.5 years STANDARD_DEVIATION 14.27 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	11 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI	28.08 kg/m2 STANDARD_DEVIATION 3.536 • n=5 Participants

PRIMARY outcome

Timeframe: Week 26

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Outcome measures

Outcome measures
Measure	300 mg n=17 Participants BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Proportion of Patients Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 26	94.1 percentage of patients achieved EASI75 Interval 71.3 to 99.9

PRIMARY outcome

Timeframe: Day 1 to Week 36

Number of Participants With Treatment-emergent Adverse Events

Outcome measures

Outcome measures
Measure	300 mg n=22 Participants BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Safety Profile of Study Treatment	13 Participants

SECONDARY outcome

Timeframe: Weeks 4, 24, and 26

BSI-045B Serum Concentration

Outcome measures

Outcome measures
Measure	300 mg n=22 Participants BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Pharmacokinetic Parameters serum concentration at Week 4	68811.694 ng/mL Standard Deviation 23168.040
Pharmacokinetic Parameters serum concentration at Week 24	63876.475 ng/mL Standard Deviation 27824.166
Pharmacokinetic Parameters serum concentration at Week 26	54324.171 ng/mL Standard Deviation 25546.549

SECONDARY outcome

Timeframe: Day 1 to Week 36

Number of Participants With Anti-BSI-045B Anti-drug Antibodies (ADA) Following BSI-045B Treatment

Outcome measures

Outcome measures
Measure	300 mg n=22 Participants BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Immunogenicity Following BSI-045B Treatment Patients with positive ADA during treatment period	0 Participants
Immunogenicity Following BSI-045B Treatment Patients with positive ADA during follow-up period	1 Participants
Immunogenicity Following BSI-045B Treatment Patients with positive ADA during the study	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 26

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Week 36

The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Week 36

The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Week 36

Patients will assess their worst itch severity over the past 24 hours using an 11 point NRS ('Worst Daily Pruritus NRS') with 0 indicating 'no itch' and 10 indicating 'worst itch imaginable'.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Week 36

The facial IGA is an instrument used in clinical trials to rate the severity of the subject's facial AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Week 36

Occurence of conjunctivitis

Outcome measures

Outcome data not reported

Adverse Events

300 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	300 mg n=22 participants at risk BSI-045B 300 mg SC QW × 4 weeks, then BSI-045B 300 mg SC Q2W through Week 24 BSI-045B: Patients will be treated with BSI-045B.
Nervous system disorders headache	22.7% 5/22 • Day 1 to Week 36

Additional Information

Kathy Zhang

Biosion, Inc.

Phone: +86 18801904945

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place