Trials / Completed
CompletedNCT05131373
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
A Phase I, Multi-center, Double-blind, Randomized, Dose Escalating, Parallel Group, Placebo-controlled Safety, Tolerability and Immunogenicity Study of ORI-A-ce001 for the Treatment of Facial Acne Vulgaris
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Acne vulgaris, or acne, is one of the most prevalent diseases worldwide, with skin conditions being one of the top causes of years lived with disability and non-fatal disease burden. Despite being one of the most prevalent diseases worldwide, the most widely used treatments in acne have changed little in the past 30 years. To date there is still no effective treatment that can prevent and cure this disease. The currently available acne therapies have been discovered several decades ago, and almost no progress was made in developments of novel, breakthrough treatment approaches. The present randomized, placebo-controlled, dose escalation, Phase 1 trial (ORI-101-PAC) is intended to investigate the safety, tolerability and immunogenicity of an acne vulgaris vaccine (ORI-A-ce001) at three different dose levels in subjects aged ≥18 years suffering from moderate facial acne vulgaris who are otherwise healthy. The present study will also generate preliminary data on efficacy (inflammatory and non-inflammatory acne lesion counts, acne severity), immunogenicity and functionality of the vaccine, as well as a possible impact on skin microbiome composition. Control groups receiving placebo are included. Data from this trial will be used to inform the design of future studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ORG101 - Experimental 1 | C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals |
| DRUG | ORG101PL - Placebo 1 | Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals |
Timeline
- Start date
- 2021-09-28
- Primary completion
- 2023-11-27
- Completion
- 2023-11-27
- First posted
- 2021-11-23
- Last updated
- 2024-01-24
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05131373. Inclusion in this directory is not an endorsement.