Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003943-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Dyax Corp. | INDUSTRY |
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This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DX-2930 300 mg every 2 weeks | Experimental | 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. |
|
| DX-2930 300 mg every 4 weeks | Experimental | 300 mg DX-2930 administered every 4 weeks by subcutaneous injection |
|
| DX-2930 150 mg every 4 weeks | Experimental | 150 mg DX-2930 administered every 4 weeks by subcutaneous injection |
|
| Placebo | Placebo Comparator | Placebo administered every 2 weeks by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DX-2930 - 300mg/2wk | Drug | 300 mg DX-2930 administered every 2 weeks by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period | 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. | From Day 0 to Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Shire Physician | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | United States | ||
| Medical Research of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37028510 | Derived | Lumry WR, Maurer M, Weller K, Riedl MA, Watt M, Yu M, Devercelli G, Meunier J, Banerji A; HELP OLE Study Group. Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2023 Jul;131(1):101-108.e3. doi: 10.1016/j.anai.2023.03.028. Epub 2023 Apr 5. | |
| 36326435 |
Not provided
Not provided
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Not provided
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 159 participants were screened and 126 participants were randomized in the ratio of 3:2:2:2 to the placebo versus DX-2930-03 arms. Of them, 125 participants were assigned to study treatment and one participant determined to be screen failure after randomization.
The study was conducted at 41 sites in the United States, United Kingdom, Italy, Germany, Canada and Jordan between 03 March 2016 (first participant first visit) and 13 April 2017 (last participant last visit).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to DX-2930 subcutaneously (SC) once in every 2 weeks (q2wks) for 26 weeks. |
| FG001 | Lanadelumab (DX-2930) 150 mg Every 4 Weeks | Participants received 150 milligram (mg) dose of DX-2930 SC once in every 4 weeks (q4wks) and matched placebo SC q2wks between DX-2930 doses for 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Sep 14, 2015 | Mar 20, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| DX-2930 - 300mg/4wk | Drug | 300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. |
|
| DX-2930 - 150mg/4wk | Drug | 150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug. |
|
| Placebo | Drug | Placebo administered every 2 weeks by subcutaneous injection. |
|
| From Day 0 to Day 182 |
| Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks | 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. | From Day 0 to Day 182 |
| Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through 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. | From Day 14 to Day 182 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| UC San Diego School of Medicine | San Diego | California | 92122 | United States |
| AIRE Medical of Los Angeles | Santa Monica | California | 90404 | United States |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | United States |
| IMMUNOe International Health & Research Centers | Centennial | Colorado | 80112 | United States |
| Asthma and Allergy Associates, P.C. | Colorado Springs | Colorado | 80907 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Institute of Asthma & Allergy, P.C. | Chevy Chase | Maryland | 20815 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02421 | United States |
| University of Michigan Hospital and Health System | Ann Arbor | Michigan | 48106 | United States |
| Midwest Immunology Clinic | Plymouth | Minnesota | 55446 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hudson-Essex Allergy, LLC | Belleville | New Jersey | 07109 | United States |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| American Health Research | Charlotte | North Carolina | 28277 | United States |
| Duke Asthma, Allergy and Airway Center | Durham | North Carolina | 27705 | United States |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45231 | United States |
| Optimed Research, LTD | Columbus | Ohio | 43235 | United States |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Austin Regional Clinic | Austin | Texas | 78731 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Intermountain Clinical Research | Draper | Utah | 84020 | United States |
| Allergy Associates of Utah | Murray | Utah | 84107 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | United States |
| Marycliff Allergy Specialists | Spokane | Washington | 99202 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Ottawa Allergy Research Corporation | Ottawa | Ontario | K1G 6C6 | Canada |
| Gordon Sussman Clinical Research Inc. | Toronto | Ontario | M4V 1R2 | Canada |
| Clinique Specialisee en Allergie de la Capitale | Québec | Quebec | G1V 4M6 | Canada |
| Charité - University of Berlin | Berlin | 10117 | Germany |
| Hautklinik und Poliklinik der Universitätsmedizin | Mainz | 55131 | Germany |
| HZRM Hamophilie-Zentrum Rhein Main | Mörfelden-Walldorf | 64546 | Germany |
| Hospital L. Sacco, Milan University | Milan | 20157 | Italy |
| Triumpharma | Amman | 11941 | Jordan |
| Sociedad Alergologica | San Juan | PR | 00918 | Puerto Rico |
| Barts Health NHS Trust Clinical Research Centre | London | E1 2ES | United Kingdom |
| Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2. |
| 36153561 | Derived | Craig TJ, Zaragoza-Urdaz RH, Li HH, Yu M, Ren H, Juethner S, Anderson J; HELP and HELP OLE Study Investigators. Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies. Allergy Asthma Clin Immunol. 2022 Sep 24;18(1):85. doi: 10.1186/s13223-022-00721-y. |
| 30480729 | Derived | Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, Busse PJ, Anderson J, Magerl M, Martinez-Saguer I, Davis-Lorton M, Zanichelli A, Li HH, Craig T, Jacobs J, Johnston DT, Shapiro R, Yang WH, Lumry WR, Manning ME, Schwartz LB, Shennak M, Soteres D, Zaragoza-Urdaz RH, Gierer S, Smith AM, Tachdjian R, Wedner HJ, Hebert J, Rehman SM, Staubach P, Schranz J, Baptista J, Nothaft W, Maurer M; HELP Investigators. Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2108-2121. doi: 10.1001/jama.2018.16773. |
| FG002 | Lanadelumab (DX-2930) 300 mg Every 4 Weeks | Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. |
| FG003 | Lanadelumab (DX-2930) 300 mg Every 2 Weeks | Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants who received any exposure to the investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to DX-2930 SC q2wks for 26 weeks. |
| BG001 | Lanadelumab (DX-2930) 150 mg Every 4 Weeks | Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. |
| BG002 | Lanadelumab (DX-2930) 300 mg Every 4 Weeks | Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. |
| BG003 | Lanadelumab (DX-2930) 300 mg Every 2 Weeks | Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period | 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. | ITT population included all randomized participants who received any exposure to the investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Attacks per 4 weeks | From Day 0 to Day 182 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment | 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. | ITT population included all randomized participants who received any exposure to the investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Attacks per 4 weeks | From Day 0 to Day 182 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks | 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. | ITT population included all randomized participants who received any exposure to the investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Attacks per 4 weeks | From Day 0 to Day 182 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through 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. | ITT population included all randomized participants who received any exposure to the investigational product. | Posted | Least Squares Mean | 95% Confidence Interval | Attacks per 4 weeks | From Day 14 to Day 182 |
|
From start of study drug administration up to Day 182
Adverse events were collected over the entire treatment period and were assigned to the treatment group without regard to the type of injection (that is placebo or active drug in the 150 mg q4wk and 300 mg q4wk groups). Number of adverse events were calculated as unique events per System Organ Class (SOC), preferred term (PT), participant and adverse event start date.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matched to DX-2930 SC q2wks for 26 weeks. | 0 | 41 | 1 | 41 | 40 | 41 |
| EG001 | Lanadelumab (DX-2930) 150 mg Every 4 Weeks | Participants received 150 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. | 0 | 28 | 0 | 28 | 25 | 28 |
| EG002 | Lanadelumab (DX-2930) 300 mg Every 4 Weeks | Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. | 0 | 29 | 3 | 29 | 26 | 29 |
| EG003 | Lanadelumab (DX-2930) 300 mg Every 2 Weeks | Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. | 0 | 27 | 2 | 27 | 23 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hereditary angioedema | Congenital, familial and genetic disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bipolar ii disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site discomfort | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hereditary angioedema | Congenital, familial and genetic disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Dec 14, 2015 | Mar 20, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Apr 21, 2016 | Mar 20, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Jan 9, 2017 | Mar 20, 2018 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Original | May 24, 2016 | Apr 19, 2018 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Amendment 1 | May 3, 2017 | Apr 19, 2018 | SAP_005.pdf |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596550 | lanadelumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Chi-squared | <0.001 | p-values are adjusted for multiple testing. | % change in mean rate (vs placebo) | -73.271 | 2-Sided | 95 | -82.379 | -59.456 | % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1) | Other | Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means. |
| Chi-squared | <0.001 | p-values are adjusted for multiple testing. | % change in mean rate (vs placebo) | -86.921 | 2-Sided | 95 | -92.828 | -76.150 | % change in mean rate corresponds to 100% * (estimated mean rate ratio - 1) | Other | Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means. |
| OG003 | Lanadelumab (DX-2930) 300 mg Every 2 Weeks | Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. |
|
|
|
| OG002 | Lanadelumab (DX-2930) 300 mg Every 4 Weeks | Participants received 300 mg dose of DX-2930 SC q4wks and matched placebo SC q2wks between DX-2930 doses for 26 weeks. |
| OG003 | Lanadelumab (DX-2930) 300 mg Every 2 Weeks | Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. |
|
|
|
| Lanadelumab (DX-2930) 300 mg Every 2 Weeks |
Participants received 300 mg dose of DX-2930 SC q2wks for 26 weeks. |
|
|
|