Trial · NCT02586805

Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

NCT02586805, Phase 3, Completed, Shire; results first posted 2018-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE. Trials, record NCT02586805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02586805

On this page

Trial

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

Title: Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
NCT number: NCT02586805
Status: Completed
Phases: Phase 3
Enrollment: 125 participants, actual
Lead sponsor: Shire
Conditions: Hereditary Angioedema (HAE)
Interventions: DX-2930 - 300mg/2wk, DX-2930 - 300mg/4wk, DX-2930 - 150mg/4wk, Placebo
First posted: 2015-10-26
Last updated: 2021-06-02
Other registries' IDs: eudract:2015-003943-20
Results first posted: 2018-04-24

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	From Day 0 to Day 182	HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Secondary	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	From Day 0 to Day 182	HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Secondary	Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks	From Day 0 to Day 182	HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Secondary	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182	From Day 14 to Day 182	HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	From Day 0 to Day 182	ITT population included all randomized participants who received any exposure to the investigational product.	Attacks per 4 weeks	LEAST_SQUARES_MEAN
SECONDARY	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	From Day 0 to Day 182	ITT population included all randomized participants who received any exposure to the investigational product.	Attacks per 4 weeks	LEAST_SQUARES_MEAN
SECONDARY	Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks	From Day 0 to Day 182	ITT population included all randomized participants who received any exposure to the investigational product.	Attacks per 4 weeks	LEAST_SQUARES_MEAN
SECONDARY	Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182	From Day 14 to Day 182	ITT population included all randomized participants who received any exposure to the investigational product.	Attacks per 4 weeks	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	Placebo	1.967	95% Confidence Interval 1.640 to 2.358	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0.480	95% Confidence Interval 0.313 to 0.735	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	0.526	95% Confidence Interval 0.358 to 0.771	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	0.257	95% Confidence Interval 0.145 to 0.458	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	Placebo	1.637	95% Confidence Interval 1.337 to 2.005	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0.314	95% Confidence Interval 0.184 to 0.535	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	0.423	95% Confidence Interval 0.276 to 0.648	Attacks per 4 weeks
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	0.208	95% Confidence Interval 0.109 to 0.396	Attacks per 4 weeks
Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks	Placebo	1.216	95% Confidence Interval 0.971 to 1.522	Attacks per 4 weeks
Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0.359	95% Confidence Interval 0.221 to 0.581	Attacks per 4 weeks

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	41
Overall Study	STARTED	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	28
Overall Study	STARTED	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	29
Overall Study	STARTED	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	27
Overall Study	COMPLETED	Placebo	35
Overall Study	COMPLETED	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	27
Overall Study	COMPLETED	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	26
Overall Study	COMPLETED	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	25
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events180

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	Arthralgia	Musculoskeletal and connective tissue disorders	Placebo	1	41	2
other	Arthralgia	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0	28	0
other	Arthralgia	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	2	29	2
other	Arthralgia	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	0	27	0
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	4	41	7
other	Back pain	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	1	28	1
other	Back pain	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	0	29	0
other	Back pain	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	1	27	1
other	Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Placebo	0	41	0
other	Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	2	28	2

1 to 10 of 180Source ClinicalTrials.gov

See all 180 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	41
Total, all-cause mortality	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0	28
Total, all-cause mortality	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	0	29
Total, all-cause mortality	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	0	27
Total, other adverse events	Placebo	40	41
Total, other adverse events	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	25	28
Total, other adverse events	Lanadelumab (DX-2930) 300 mg Every 4 Weeks	26	29
Total, other adverse events	Lanadelumab (DX-2930) 300 mg Every 2 Weeks	23	27
Total, serious adverse events	Placebo	1	41
Total, serious adverse events	Lanadelumab (DX-2930) 150 mg Every 4 Weeks	0	28

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30480729	DERIVED	PubMed
36153561	DERIVED	PubMed
36326435	DERIVED	PubMed
37028510	DERIVED	PubMed

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 comparisons0

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

None in this release.

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/NCT02586805

GET https://conductscience.org/api/trials/v1/NCT02586805/events?page=2

API reference For AI assistants