ABP 959 - proposed biosimilar to eculizumab ( DrugBank: Eculizumab )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 62 | Paroxysmal nocturnal hemoglobinuria | 1 |
62. Paroxysmal nocturnal hemoglobinuria
Clinical trials : 292 / Drugs : 151 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 108
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-001418-27-SE (EUCTR) | 20/02/2020 | 08/11/2019 | This trial is designed to determine what effects the investigational medicine, ABP 959, has on the human body, and what effects the body has on theinvestigational medicine after you have been given it, and if this iscomparable to what is seen for the licensed medicine, eculizumab, inpatients with Paroxysmal Nocturnal Hemoglobinuria (PNH).This study will assess if the investigational medicine is safe and effective intreating PNH compared to the licensed medicine. | A RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED PHASE 3 STUDY EVALUATING THE EFFICACY AND SAFETY OF ABP 959 COMPARED WITH ECULIZUMAB IN ADULT SUBJECTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) - Not applicable | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: ABP 959 Product Code: ABP 959 INN or Proposed INN: ECULIZUMAB Other descriptive name: ABP 959 - proposed biosimilar to eculizumab Trade Name: Soliris Product Name: Soliris INN or Proposed INN: ECULIZUMAB Trade Name: Soliris Product Name: Soliris | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 3 | United States;Portugal;Taiwan;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Brazil;Germany;Netherlands;Norway;Sweden |