Trial Outcomes & Findings for Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) (NCT NCT05030350)
NCT ID: NCT05030350
Last Updated: 2025-10-21
Results Overview
Subjects with at least one Serious Adverse Event (SAE)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
481 participants
Primary outcome timeframe
12 months
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
PH94B 3.2 Micrograms
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Overall Study
STARTED
|
481
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
481
|
Reasons for withdrawal
| Measure |
PH94B 3.2 Micrograms
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
Lost to Follow-up
|
35
|
|
Overall Study
Pregnancy
|
2
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
60
|
|
Overall Study
Study terminated by sponsor
|
349
|
|
Overall Study
Positive Drug Screen
|
4
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
Baseline characteristics by cohort
| Measure |
PH94B
n=481 Participants
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
481 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 12.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
318 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
481 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsSubjects with at least one Serious Adverse Event (SAE)
Outcome measures
| Measure |
PH94B
n=481 Participants
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least one TEAE
|
273 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least 1 Mild TEAE
|
186 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least 1 Moderate TEAE
|
78 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least 1 Severe TEAE
|
9 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least 1 TEAE leading to study discontinuation
|
14 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Subjects with at least 1 SAE
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: V 2 (Baseline), V 3 (Month 1), V 4 (Month 2), V 5 (Month3), V 6 (Month 4), V 7 (Month 5), V 8 (Month 6), V 9 (Month 7), V 10 (Month 8), V11 (Month 9)Population: The number analyzed differs from overall number analyze as PH94B-CL030 was terminated early by the sponsor
The LSAS is a clinician-rated scale that has been shown to be sensitive to treatment-related change in social anxiety symptoms. The scale consists of 24 items. Each item is given 2 ratings: fear or anxiety on scale of 0 to 3 (with 0 = none and 3 = severe) and avoidance on a scale of 0 to 3 (with 0 = never and 3 = usually), with a total maximum overall score of 144. The sum of the 24 fear or anxiety items and the sum of the 24 avoidance items are combined for a total LSAS score.
Outcome measures
| Measure |
PH94B
n=480 Participants
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 2 (Baseline)
|
93.4 score on a scale
Standard Deviation 18.79
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 3 (Month 1)
|
76.6 score on a scale
Standard Deviation 24.63
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 4 (Month 2)
|
73.0 score on a scale
Standard Deviation 25.09
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 5 (Month 3)
|
67.6 score on a scale
Standard Deviation 25.58
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 6 (Month 4)
|
66.0 score on a scale
Standard Deviation 24.85
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 7 (Month 5)
|
64.8 score on a scale
Standard Deviation 24.91
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 8 (Month 6)
|
65.2 score on a scale
Standard Deviation 23.70
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 9 (Month 7)
|
61.1 score on a scale
Standard Deviation 26.44
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 10 (Month 8)
|
54.0 score on a scale
Standard Deviation 21.52
|
|
Change in Total Liebowitz Social Anxiety Scale (LSAS) Scores Over Time With Use of PH94B
Visit 11 (Month 9)
|
54.4 score on a scale
Standard Deviation 7.76
|
Adverse Events
PH94B
Serious events: 6 serious events
Other events: 137 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
PH94B
n=481 participants at risk
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.21%
1/481 • 12 months
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
1/481 • 12 months
|
|
Infections and infestations
Pelvic abscess
|
0.21%
1/481 • 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/481 • 12 months
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.21%
1/481 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.21%
1/481 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.21%
1/481 • 12 months
|
Other adverse events
| Measure |
PH94B
n=481 participants at risk
PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day.
|
|---|---|
|
Nervous system disorders
Headache
|
17.0%
82/481 • 12 months
|
|
Infections and infestations
COVID-19
|
11.4%
55/481 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place