Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT04444752)

Last Updated: 2023-08-01

Results Overview

EASI=Eczema Area Severity Index is a validated physician score for signs of atopic dermatitis. EASI can range from 0 to 72. An EASI score of 0 indicates clear/no eczema, 0.1 to 1.0 almost clear, 1.1 to 7 mild disease, 7.1 to 21 moderate disease, 21.1 to 50 severe disease, and 51-72 indicates very severe disease. EASI Sub-scale ranges are as follows: Head/neck can range from 0-7.2, Trunk 0-14.4, Upper Extremities 0-21.6, Lower Extremities can range from 0-28.8. To calculate EASI, % involvement is first assessed by body region with an Area involvement Score of 0-6 for each region: 0=0%, 1=1-9%, 2=10-29%, 3=30-39%, 4=50-69%, 5=70-89%, 6=90-100% involvement. Then 4 attributes (Erythema, Edema/Papulation, Excoriation, and Lichenification) are scored for severity (0= none, 1=mild, 2=moderate, 3=severe). A multiplier is applied head/neck=0.1, trunk=0.2, upper extremities= 0.3, lower extremities=0.4. The total EASI score is the sum of 4 regional sub-scores.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

226 participants

Primary outcome timeframe

Reduction from baseline to 16 weeks

Results posted on

2023-08-01

Participant Flow

Patients were recruited based on physician referrral at academic and non-academic clinical centers between Jun 2020 and Sep 2021; 394 patients were screened. The first participant was randomized to treatment on 30 Jun 2020 and the last patient was randomized in April 2021. The last patient last visit was 22 Sept 2021.

After providing informed consent, patients were assessed for study eligibility within 45 days before the baseline visit. Of the 394 patients screeened, 226 patients met the eligibility criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	CBP-201 150 Q2W CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks
Overall Study STARTED	57	57	56	56
Overall Study COMPLETED	46	45	50	40
Overall Study NOT COMPLETED	11	12	6	16

Reasons for withdrawal

Reasons for withdrawal
Measure	CBP-201 150 Q2W CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks
Overall Study Adverse Event	1	0	0	2
Overall Study Lost to Follow-up	2	6	2	5
Overall Study Physician Decision	0	0	0	2
Overall Study Pregnancy	0	0	0	1
Overall Study Withdrawal by Subject	6	5	3	4
Overall Study Protocol Violation	1	1	0	0
Overall Study Patient moving out of town	1	0	0	1
Overall Study Lack of Efficacy	0	0	0	1
Overall Study Death	0	0	1	0

Baseline Characteristics

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBP-201 150 Q2W n=57 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W n=57 Participants CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W n=56 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo n=56 Participants Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks	Total n=226 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	54 Participants n=7 Participants	52 Participants n=5 Participants	54 Participants n=4 Participants	212 Participants n=21 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Age, Continuous	39.5 years STANDARD_DEVIATION 15.98 • n=5 Participants	39.6 years STANDARD_DEVIATION 14.79 • n=7 Participants	41.7 years STANDARD_DEVIATION 15.22 • n=5 Participants	39.6 years STANDARD_DEVIATION 14.79 • n=4 Participants	40.1 years STANDARD_DEVIATION 15.13 • n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	27 Participants n=7 Participants	28 Participants n=5 Participants	36 Participants n=4 Participants	121 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	20 Participants n=4 Participants	105 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	24 Participants n=4 Participants	92 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	33 Participants n=7 Participants	29 Participants n=5 Participants	32 Participants n=4 Participants	134 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	52 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	31 Participants n=21 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	38 Participants n=7 Participants	32 Participants n=5 Participants	32 Participants n=4 Participants	132 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment New Zealand	5 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants	6 participants n=4 Participants	19 participants n=21 Participants
Region of Enrollment United States	40 participants n=5 Participants	47 participants n=7 Participants	41 participants n=5 Participants	44 participants n=4 Participants	172 participants n=21 Participants
Region of Enrollment China	11 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants	6 participants n=4 Participants	32 participants n=21 Participants
Region of Enrollment Australia	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
EASI Score	24.61 units on a scale STANDARD_DEVIATION 10.471 • n=5 Participants	27.57 units on a scale STANDARD_DEVIATION 11.776 • n=7 Participants	23.08 units on a scale STANDARD_DEVIATION 8.218 • n=5 Participants	25.16 units on a scale STANDARD_DEVIATION 9.021 • n=4 Participants	25.11 units on a scale STANDARD_DEVIATION 10.042 • n=21 Participants
IGA Score IGA 3 = Moderate disease	43 Participants n=5 Participants	34 Participants n=7 Participants	40 Participants n=5 Participants	39 Participants n=4 Participants	156 Participants n=21 Participants
IGA Score IGA 4 = Severe disease	14 Participants n=5 Participants	23 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	70 Participants n=21 Participants
BSA	39.86 percentage STANDARD_DEVIATION 19.145 • n=5 Participants	43.11 percentage STANDARD_DEVIATION 20.738 • n=7 Participants	37.34 percentage STANDARD_DEVIATION 19.479 • n=5 Participants	37.71 percentage STANDARD_DEVIATION 18.341 • n=4 Participants	39.52 percentage STANDARD_DEVIATION 19.456 • n=21 Participants

PRIMARY outcome

Timeframe: Reduction from baseline to 16 weeks

Population: All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug based on planned treatment assignment (ie, "as randomized").

Outcome measures

Outcome measures
Measure	CBP-201 150 Q2W n=57 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W n=57 Participants CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W n=56 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo n=56 Participants Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks
Percent Reduction in EASI Score From Baseline to Week 16	57.56 percent reduction from Baseline Standard Error 4.610	63.03 percent reduction from Baseline Standard Error 4.961	63.50 percent reduction from Baseline Standard Error 4.661	39.67 percent reduction from Baseline Standard Error 4.638

SECONDARY outcome

Timeframe: Response Rate at 16 weeks

Population: All efficacy analyses were carried out using the FAS (all randomized subjects who received at least part of an SC dose of study drug), based on planned treatment assignment (ie, "as randomized").

Validated Investigator Global Assessment Score (vIGA) is assigned by the physician based on morphologic presentation of the disease in the clinic. The physician considers extent and severity of erythema, induration/papulation, lichenification, and oozing/crusting. A vIGA Score of 0=Clear, 1=Almost Clear, 2= Mild dermatitis, 3=Moderate dermatitis, and 4= Severe dermatitis. Patients are required to have a baseline IGA of 3 or 4. The response rate or percentage of patients achieving a vIGA of 0 or 1 (improved to clear or almost clear) at week 16 is the outcome.

Outcome measures

Outcome measures
Measure	CBP-201 150 Q2W n=57 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W n=57 Participants CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W n=56 Participants CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo n=56 Participants Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks
vIGA of 0/1 at Week 16	9 Participants	16 Participants	11 Participants	5 Participants

Adverse Events

CBP-201 150 Q2W

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

CBP-201 300 Q2W

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

CBP-201 300 Q4W

Serious events: 2 serious events

Other events: 34 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CBP-201 150 Q2W n=57 participants at risk CBP-201 1800 mg, 600 mg Loading dose followed by 150 mg Q2W for 16 weeks	CBP-201 300 Q2W n=57 participants at risk CBP-201 3000 mg, 600 mg Loading dose followed by 300 mg Q2W for 16 weeks	CBP-201 300 Q4W n=56 participants at risk CBP-201 1800 mg, 600 mg Loading dose followed by 300 mg Q4W for 16 weeks alternating with 2 mLs matched volume placebo Q4W for 16 weeks	Placebo n=56 participants at risk Placebo, 4 mLs matched loading dose volume follwed by 2 mls matched volume Q2W for 16 weeks
Gastrointestinal disorders Vomiting	1.8% 1/57 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Hepatobiliary disorders Cholelithiasis	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	1.8% 1/56 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Infections and infestations Pneumonia	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	1.8% 1/56 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Cardiac disorders Angina pectoris	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	1.8% 1/56 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Cardiac disorders Cardiac arrest	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	1.8% 1/56 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Gastrointestinal disorders Nausea	1.8% 1/57 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	1.8% 1/56 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.
Nervous system disorders Headache	1.8% 1/57 • Number of events 1 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/57 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.	0.00% 0/56 • Adverse events were reported from the time the subject signed the informed consent and continued through the scheduled last visit (32 weeks after baseline visit), or if unresolved, until clinical recovery was complete. An adverse event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. All AEs will be reported along with causality (related or not related) and Severity (CTCAE grading 1-5). In addition, AEs will be considered AEs of Special Interest (AESI) if they are involve ophthalmic complications (conjunctivitis or keratitis). Serious AEs will be reported within 24 hours to the Sponsor and CRO.

Other adverse events

Additional Information

Malinda Longphre

Head of Clinical Operations US

Phone: +15105203361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place