Trial · NCT02031679

Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines

NCT02031679, Phase 2, Completed, Johns Hopkins University; results first posted 2017-07-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines. Trials, record NCT02031679. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02031679

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Trial

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

Title: Efficacy and Safety of Chemoattractant Receptor-homologous Molecule Expressed on T Helper Type 2 (CRTh2) Antagonist AZD1981 in Chronic Idiopathic Urticaria (CIU) Antihistamines
NCT number: NCT02031679
Status: Completed
Phases: Phase 2
Enrollment: 38 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Chronic Idiopathic Urticaria
Interventions: AZD1981, Placebo
First posted: 2014-01-09
Last updated: 2017-07-12
Results first posted: 2017-07-12
Limitations and caveats: Among the limitations of this study are the small number of subjects, short duration of therapy and washout periods, and the lack of skin tissue biopsies to correspond with peripheral blood leukocyte findings.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	7 Days	The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0-3, with 0 = no itch and 3 is severe itch) and number of hives (0-3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day. The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days. The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period.
Secondary	The Number of Participants With Adverse Events	8 weeks	The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs. In particular we will measure CBC's with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity.
Secondary	The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape	Baseline, End of treatment, end of washout	The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer. Cellular scatter was established with buffer and then several doses of PGD2 stimulation.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	7 Days	One placebo subject had diary data compromised by device malfunction so only full data for 11 subjects were analyzed	UAS7 Scores	MEAN
SECONDARY	The Number of Participants With Adverse Events	8 weeks		participants with adverse events	NUMBER
SECONDARY	The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape	Baseline, End of treatment, end of washout	Insufficient samples were obtained for one active and 2 placebo patients.	Mean fluorescence units area under curve	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	AZD1981	Baseline	20.46	Standard Error 3.655	UAS7 Scores
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	Placebo	Baseline	24.59	Standard Error 3.463	UAS7 Scores
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	AZD1981	End of Treatment	18.83	Standard Error 3.779	UAS7 Scores
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	Placebo	End of Treatment	18	Standard Error 3.614	UAS7 Scores
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	AZD1981	End of Washout	15.79	Standard Error 3.726	UAS7 Scores
The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)	Placebo	End of Washout	19	Standard Error 3.465	UAS7 Scores
The Number of Participants With Adverse Events	AZD1981		9		participants with adverse events
The Number of Participants With Adverse Events	Placebo		8		participants with adverse events
The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape	AZD1981	Baseline	1521.317	Standard Deviation 138.146	Mean fluorescence units area under curve
The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape	Placebo	Baseline	1472.867	Standard Deviation 184.401	Mean fluorescence units area under curve

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	AZD1981	14
Overall Study	STARTED	Placebo	14
Overall Study	COMPLETED	AZD1981	14
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	AZD1981	0
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events26

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	Events
other	Headache	Nervous system disorders	AZD1981	0	14	0
other	Headache	Nervous system disorders	Placebo	2	12	2
other	Musculoskeletal	Musculoskeletal and connective tissue disorders	AZD1981	3	14	3
other	Musculoskeletal	Musculoskeletal and connective tissue disorders	Placebo	1	12	1
other	Infection	Infections and infestations	AZD1981	5	14	5
other	Infection	Infections and infestations	Placebo	5	12	5
other	Sleep impairment	Psychiatric disorders	AZD1981	1	14	1
other	Sleep impairment	Psychiatric disorders	Placebo	1	12	1
other	Respiratory disorders (non-infectious)	Respiratory, thoracic and mediastinal disorders	AZD1981	0	14	0
other	Respiratory disorders (non-infectious)	Respiratory, thoracic and mediastinal disorders	Placebo	0	12	0

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZD1981	0	14
Total, all-cause mortality	Placebo	0	12
Total, other adverse events	AZD1981	9	14
Total, other adverse events	Placebo	8	12
Total, serious adverse events	AZD1981	0	14
Total, serious adverse events	Placebo	0	12

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
AZD1981 vs Placebo: deaths from any cause	Trial comparisons
AZD1981 vs Placebo: 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/NCT02031679

GET https://conductscience.org/api/trials/v1/NCT02031679/events?page=2

API reference For AI assistants