Clinical Trials in Poland / NCT06846398
Active, not recruiting
Phase 2
A Phase 2 in Adult Subjects With Hereditary Angioedema
NCT06846398 · tracked via the Priya Life Science Poland tracker
Condition(s) studied
Hereditary Angioedema (HAE)
Investigational drug(s) / intervention(s)
BW-20805: SC administrations of BW-20805 600 mg on Day1 to Day673
BW-20805: SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673
BW-20805: SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589
Study summary
A Phase 2 in Adult Subjects with Hereditary Angioedema
Eligibility
Inclusion Criteria:
* Must have given written informed consent and be able to comply with all study requirements.
* Males or females 18 to 70 years of age at the time of informed consent.
* Documented diagnosis of HAE-1/HAE-2.
* At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
* Access to and ability to use ≥ 1 acute medication(s)
* Female subjects must be non-pregnant;non-lactating, and either surgically sterile
* Male subjects with WOCBP partners, dual contraception is required if no surgically sterile
Exclusion Criteria:
* Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
* History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
* Have undergone major surgery within 3 months prior to screening.
* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
* History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
* Prior treatment with any oligonucleotides within 6 months if single dose or 12 months if multiple doses prior to screening.
* Exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening.
* With ANY of the abnormalities in clinical laboratory tests at screening and run-in period
* Clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening.
* Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilis infection
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
Primary outcome measure(s)
- To determine the prophylactic effect of in HAE attack rate. — from baseline to Day169
Change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day169
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute for Asthma and Allergy - Wheaton | Silver Spring | Maryland | |
| Washington University School of Medicine | St Louis | Missouri | |
| Duke University Medicine Center | Durham | North Carolina | |
| Penn State Milton S. Hershey MC - Penn State | Hershey | Pennsylvania | |
| Inova Clinical Trials and Research Center | Falls Church | Virginia | |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | |
| Yantai Yuhuangding Hospital | Yantai | Shandong | |
| West China Hospital, Sichuan University | Chengdu | Sichaun | |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | |
| Universitätsmedizin der Johannes Gutenberg | Mainz | Rhineland-Palatinate | |
| Charité - Universitätsmedizin Berlin | Berlin | State of Berlin | |
| Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco | Catania | Catania | |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Florence | |
| Azienda Ospedale - Universita di Padova | Padova | PD | |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla |
Other trials for the same condition
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Enrolling by invitation
A Study of Navenibart in Participants With Hereditary Angioedema
Active, not recruiting
A Long-Term Study of Navenibart in Participants With Hereditary Angioedema
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06846398 on ClinicalTrials.gov ↗ ← All trials in Poland