Trial · NCT03436797

A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria

NCT03436797, Phase 2, Completed, Allakos Inc.; results first posted 2024-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria. Trials, record NCT03436797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03436797

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria
NCT number: NCT03436797
Status: Completed
Phases: Phase 2
Enrollment: 47 participants, actual
Lead sponsor: Allakos Inc.
Conditions: Chronic Urticaria
Interventions: AK002
First posted: 2018-02-19
Last updated: 2024-03-04
Results first posted: 2024-01-23

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	Baseline to Week 22 (Main Study Phase)	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 \[MCID\]).
Other	Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase	Through study completion, up to 52 weeks (Extension 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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	Baseline to Week 22 (Main Study Phase)	Modified intention-to-treat	Score on a scale	MEAN
OTHER_PRE_SPECIFIED	Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase	Through study completion, up to 52 weeks (Extension Dosing Phase)	5 subjects from the main study were enrolled in the Extended Dosing Phase.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	CholU		6.5	Standard Deviation 6.15	Score on a scale
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	UF-Cohort		3.4	Standard Deviation 4.09	Score on a scale
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	CSU-XN		11.1	Standard Deviation 4.07	Score on a scale
Change in Urticaria Control Test (UCT) Score From Baseline to Week 22 in the Main Study Phase	CSU-XF		4.8	Standard Deviation 6.97	Score on a scale
Safety and Tolerability of up to 12 Additional Doses of AK002 in Subjects With CU in the Extended Dosing Phase	AK002	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	AK002	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	AK002	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	AK002	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	AK002	Subjects with ≥1 treatment-related serious adverse events	0		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Main Study	STARTED	AK002	47
Main Study	COMPLETED	AK002	37
Main Study	NOT COMPLETED	AK002	10
Extended Dosing	STARTED	AK002	5
Extended Dosing	COMPLETED	AK002	4
Extended Dosing	NOT COMPLETED	AK002	1

Source ClinicalTrials.gov

Adverse events74

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Chest pain	General disorders	AK002 Main Study	3	47
other	Chest pain	General disorders	AK002 Extended Dosing	0	5
other	Fatigue	General disorders	AK002 Main Study	3	47
other	Fatigue	General disorders	AK002 Extended Dosing	0	5
other	Influenza like illness	General disorders	AK002 Main Study	3	47
other	Influenza like illness	General disorders	AK002 Extended Dosing	0	5
other	Pyrexia	General disorders	AK002 Main Study	3	47
other	Pyrexia	General disorders	AK002 Extended Dosing	0	5
other	Infusion related reaction	Injury, poisoning and procedural complications	AK002 Main Study	20	47
other	Infusion related reaction	Injury, poisoning and procedural complications	AK002 Extended Dosing	3	5

1 to 10 of 74Source ClinicalTrials.gov

See all 74 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AK002 Main Study	1	47
Total, all-cause mortality	AK002 Extended Dosing	0	5
Total, other adverse events	AK002 Main Study	33	47
Total, other adverse events	AK002 Extended Dosing	5	5
Total, serious adverse events	AK002 Main Study	4	47
Total, serious adverse events	AK002 Extended Dosing	1	5

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AK002 Main Study vs AK002 Extended Dosing: deaths from any cause	Trial comparisons
AK002 Main Study vs AK002 Extended Dosing: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03436797

GET https://conductscience.org/api/trials/v1/NCT03436797/events?page=2

API reference For AI assistants