Overview
Sponsor-declared trial summary
Onchocerciasis (river blindness): is an infectious disease caused by Onchocerca volvulus, a parasitic nematode worm. The disease is contracted through the bite of an infected blackfly of the genus Simulium, which transmits third-stage infective larvae. An estimated 18 million people suffer from onchocerciasis, with 99% cases in 31 African countries, and 187 million people at risk Onchocercal dermatitis is the most common symptom of the disease, but severe visual impairment and blindness are the most severe complication, and onchocerciasis is the world’s second-leading infectious cause of blindness. Programs for the treatment and control of onchocerciasis through mass drug administration of ivermectin have been in place for over 20 years. However, they require patients to be given treatment (ivermectin) at regular intervals for the life of the adult worm (up to 15 years), making implementation extremely difficult in endemic countries. Emodepside is a registered drug for animal health, marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug.
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Trial duration
- 6 May 2024 → 27 Aug 2024
- Decision date (initial)
- 2024-03-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Onchocerciasis (river blindness): is an infectious disease caused by Onchocerca volvulus, a parasitic nematode worm. The disease is contracted through the bite of an infected blackfly of the genus Simulium, which transmits third-stage infective larvae. An estimated 18 million people suffer from onchocerciasis, with 99% cases in 31 African countries, and 187 million people at risk Onchocercal dermatitis is the most common symptom of the disease, but severe visual impairment and blindness are the most severe complication, and onchocerciasis is the world’s second-leading infectious cause of blindness. Programs for the treatment and control of onchocerciasis through mass drug administration of ivermectin have been in place for over 20 years. However, they require patients to be given treatment (ivermectin) at regular intervals for the life of the adult worm (up to 15 years), making implementation extremely difficult in endemic countries. Emodepside is a registered drug for animal health, marketed by Bayer Animal Health GmbH under the name of Profender® (in combination with praziquantel) or Procox® (in combination with toltrazuril). It is a cyclooctadepsipeptide anthelmintic drug.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061201 | Helminthic infection | 100000004862 |
| 20.0 | PT | 10030314 | Onchocerciasis | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-05-06 | 2024-08-27 | 2024-05-07 | 2024-05-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-11 | Germany | Acceptable 2024-02-29
|
2024-03-01 |