SHP643-303 - Efficacy and Safety of Lanadelumab in Angioedema
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH) and Acquired Angioedema (AAE) Due to C1-INH Deficiency
IRAS ID
282768
Contact name
Hilary Longhurst
Contact email
Sponsor organisation
Dyax Corporation, a Takeda company
Eudract number
2019-001703-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 20 days
Research summary
This is a Phase 3, multicentre, randomised, placebo-controlled, double-blind study of lanadelumab (study drug) in participants with certain types of angioedema (swelling of the deeper layers of the skin).
The study will enrol adolescents (12 to <16years of age) and adult participants with a certain type of angioedema called non-histaminergic angioedema with normal CI-inhibitor and adult participants aged 30 years or above with a type of angioedema acquired angioedema (AAE) due to CI-inhibitor deficiency.
This main purpose of the study is to investigate how well the study drug works (efficacy) in preventing angioedema attacks compared against placebo (looks like study drug but contains no active ingredients). The study will also investigate the safety of the study drug, how the study drug is absorbed, distributed and removed by the body (pharmacokinetics), how the study drug has effects on the body (pharmacodynamics) and the effect the study drug has on participants quality of life.
The study drug is a human antibody. Antibody medications, such as landelumab, are made from human blood components in the laboratory and look like antibodies made by the human body, except they specifically block certain substances. The study drug aims to inhibit excess amount of pKal: a protein in the body that is generated during an angioedema attack. The study drug is given as a subcutaneous (SC – under the skin) injection every 2 weeks.
120 participants will be enrolled globally. The chance of a participant receiving the study drug landelumab is 2 in 3. Each participants duration is expected to be 40 weeks.
The study consists of the following:
- Screening period: Up to 4 weeks before starting study treatment.
- A 4-8 week observation period.
- 26-week treatment period:
- Follow-up period: This will last for 2 weeks after the last dose of study medication is received.REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0892
Date of REC Opinion
28 Aug 2020
REC opinion
Further Information Favourable Opinion