Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria (NCT NCT03436797)

Last Updated: 2024-03-04

Results Overview

The UCT score consists of 4 items, and each UCT item has 5 answer options (scored with 0-4 points), where low points indicate high disease activity and low disease control of chronic urticaria. The UCT score, ranging from 0 to 16, is calculated by adding all 4 individual item scores. A UCT score of 16 points indicates complete disease control and a change of the UCT score of 3 or more points was regarded as clinically relevant (minimal clinically important difference \[MCID\]).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Baseline to Week 22 (Main Study Phase)

Results posted on

2024-03-04

Participant Flow

47 subjects were enrolled in the main study and received at least one dose of AK002. 45 subjects had at least one post-baseline assessment of the primary efficacy variable and were reported in the baseline period. 5 subjects from the main study were allowed the option to receive extended dosing with up to 12 additional doses of AK002.

no pre-assignment was done

Participant milestones

Participant milestones
Measure	AK002 For the main study phase, single doses of AK002 were administered by IV infusion every 28 days at Weeks 0, 4, 8, 12, 16, and 20. For the extended dosing phase, single doses of AK002 were administered by IV infusion on Extended Dosing Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, and 309. The arm included all subjects who were enrolled.
Main Study STARTED	47
Main Study COMPLETED	37
Main Study NOT COMPLETED	10
Extended Dosing STARTED	5
Extended Dosing COMPLETED	4
Extended Dosing NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AK002 For the main study phase, single doses of AK002 were administered by IV infusion every 28 days at Weeks 0, 4, 8, 12, 16, and 20. For the extended dosing phase, single doses of AK002 were administered by IV infusion on Extended Dosing Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, and 309. The arm included all subjects who were enrolled.
Main Study Withdrawal by Subject	2
Main Study Adverse Event	4
Main Study Lost to Follow-up	1
Main Study Death	1
Main Study Non-Specific	2
Extended Dosing Patient decision	1

Baseline Characteristics

45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AK002 n=45 Participants For the main study, single doses of AK002 were administered by IV infusion every 28 days at Weeks 0, 4, 8, 12, 16, and 20. The arm included all subjects who were enrolled in the main study, did receive at least 1 dose of the study drug, and had at least 1 post-baseline assessment of the primary efficacy variable (=modified intention-to-treat population, mITT). For the extended dosing phase, the arm included all subjects who were enrolled in the extended dosing and received at least 1 dose of the study drug.
Age, Continuous Main Study Phase	42 years n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Age, Continuous Extended Dosing Phase	43 years n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Sex: Female, Male Main Study Phase · Female	34 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Sex: Female, Male Main Study Phase · Male	11 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Sex: Female, Male Extended Dosing Phase · Female	5 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Sex: Female, Male Extended Dosing Phase · Male	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Main Study Phase · Hispanic or Latino	2 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Main Study Phase · Not Hispanic or Latino	43 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Main Study Phase · Unknown or Not Reported	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Extended Dosing Phase · Hispanic or Latino	1 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Extended Dosing Phase · Not Hispanic or Latino	4 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Ethnicity (NIH/OMB) Extended Dosing Phase · Unknown or Not Reported	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · American Indian or Alaska Native	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · Asian	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · Black or African American	1 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · White	44 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · More than one race	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Main Study Phase · Unknown or Not Reported	0 Participants n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · American Indian or Alaska Native	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · Asian	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · Black or African American	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · White	5 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · More than one race	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Race (NIH/OMB) Extended Dosing Phase · Unknown or Not Reported	0 Participants n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Region of Enrollment United States	16 Participants n=45 Participants
Region of Enrollment Germany	29 Participants n=45 Participants
Urticaria Control Test (UCT) Score Main Study Phase	4.4 Score on a scale STANDARD_DEVIATION 3.1 • n=45 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.
Urticaria Control Test (UCT) Score Extended Dosing Phase	1.6 Score on a scale STANDARD_DEVIATION 1.5 • n=5 Participants • 45 subjects in the Main Study Phase. 5 subjects entered the Extended Dosing Phase.

PRIMARY outcome

Timeframe: Baseline to Week 22 (Main Study Phase)

Population: Modified intention-to-treat

Outcome measures

Outcome measures
Measure	CholU n=11 Participants The CholU cohort included subjects with Cholinergic Urticaria.	UF-Cohort n=10 Participants The UF cohort included subjects with Urticaria Factitia.	CSU-XN n=13 Participants The CSU-XN cohort included XOLAIR® (omalizumab) naïve subjects with Chronic Spontaneous Urticaria (CSU).	CSU-XF n=11 Participants The CSU-XF cohort included subjects with Chronic Spontaneous Urticaria (CSU) who did not achieve an adequate response to XOLAIR® (omalizumab) in the opinion of the Investigator.
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	6.5 Score on a scale Standard Deviation 6.15	3.4 Score on a scale Standard Deviation 4.09	11.1 Score on a scale Standard Deviation 4.07	4.8 Score on a scale Standard Deviation 6.97

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, up to 52 weeks (Extension Dosing Phase)

Population: 5 subjects from the main study were enrolled in the Extended Dosing Phase.

Adverse events were assessed during the Extended Dosing Phase of the study, and only the 5 subjects who entered the Extended Dosing Phase were included.

Outcome measures

Outcome measures
Measure	CholU n=5 Participants The CholU cohort included subjects with Cholinergic Urticaria.	UF-Cohort The UF cohort included subjects with Urticaria Factitia.	CSU-XN The CSU-XN cohort included XOLAIR® (omalizumab) naïve subjects with Chronic Spontaneous Urticaria (CSU).	CSU-XF The CSU-XF cohort included subjects with Chronic Spontaneous Urticaria (CSU) who did not achieve an adequate response to XOLAIR® (omalizumab) in the opinion of the Investigator.
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase Subjects with ≥1 adverse events	5 Participants	—	—	—
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase Subjects with ≥1 treatment-related adverse events	4 Participants	—	—	—
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase Subjects with an adverse event leading to study drug discontinuation	0 Participants	—	—	—
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase Subjects with ≥1 serious adverse events	1 Participants	—	—	—
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase Subjects with ≥1 treatment-related serious adverse events	0 Participants	—	—	—

Adverse Events

AK002 Main Study

Serious events: 4 serious events

Other events: 33 other events

Deaths: 1 deaths

AK002 Extended Dosing

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AK002 Main Study n=47 participants at risk This arm included all subjects who were enrolled in the Main Study Phase	AK002 Extended Dosing n=5 participants at risk This arm included all subjects from the main study who were enrolled in the Extended Dosing Phase
Vascular disorders Hypertension	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Injury, poisoning and procedural complications Tendon rupture	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Cardiac disorders Cardiac failure acute	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Abdominal pain upper	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Appendicitis	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enchondromatosis	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.

Other adverse events

Additional Information

Medical Information

Allakos

Phone: 650-597-5002

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clinical Trial Agreement contains a limit on publication of results following completion of the trial. PIs are not allowed to publish results until a joint publication for the multicenter study or a set period of time. After that time, PIs may only publish results from their portion of the study.
Publication restrictions are in place

Restriction type: OTHER

Measure	AK002 Main Study n=47 participants at risk This arm included all subjects who were enrolled in the Main Study Phase	AK002 Extended Dosing n=5 participants at risk This arm included all subjects from the main study who were enrolled in the Extended Dosing Phase
General disorders Chest pain	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
General disorders Fatigue	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
General disorders Influenza like illness	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
General disorders Pyrexia	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Injury, poisoning and procedural complications Infusion related reaction	42.6% 20/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	60.0% 3/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Nervous system disorders Headache	19.1% 9/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	40.0% 2/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Abdominal pain upper	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Diarrhoea	8.5% 4/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Musculoskeletal and connective tissue disorders Back pain	8.5% 4/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	0.00% 0/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Musculoskeletal and connective tissue disorders Arthralgia	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Nasopharyngitis	21.3% 10/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	80.0% 4/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Sinusitis	6.4% 3/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Cardiac disorders Sinus arrhythmia	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Endocrine disorders Goitre	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Abdominal pain	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Nausea	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Gastrointestinal disorders Vomiting	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
General disorders Inflammation	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Bronchitis	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Conjunctivitis bacterial	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Gastrointestinal infection	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Oral herpes	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	40.0% 2/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Tinea manuum	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Infections and infestations Tinea pedis	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Nervous system disorders Disturbance in attention	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Respiratory, thoracic and mediastinal disorders Cough	2.1% 1/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/47 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.	20.0% 1/5 • Adverse events were reported from the first dose of AK002 until the end of Follow-up (Week 28 in the Main Study Phase, Week 52 in the Extended Dosing Phase). Adverse events were reported systematically.