Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORG101- Experimental 1 · 1 trial · 2 indications
Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Incidence of AEs and SAEs
Number of participants with AEs or SAEs as assessed by physical examination, vital signs, local skin responses, as assessed by treatment arm (vaccine and placebo)
Clinically significant change from the baseline in laboratory data as compared to placebo
Clinically significant change from the baseline in vital signs as compared to placebo
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Clinically significant change from the baseline in physical examination, as compared to placebo
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m. |
| Placebo 1 | PLACEBO_COMPARATOR | Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections |
| Name | Type | Description |
|---|---|---|
| ORG101 - Experimental 1 | DRUG | C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals |
| ORG101PL - Placebo 1 | DRUG | Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals |
Inclusion Criteria: - Male or female subject aged ≥18 years at the time of informed consent signature * Female subjects of childbearing potential must have a negative serum or urine pregnancy test at Screening and before vaccination and must be willing to practice a highly effective method of contr...
ORG101- Experimental 1 is an investigational small molecule being developed for the treatment of acne vulgaris, a common skin condition characterized by pimples, blackheads, and whiteheads. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ORG101- Experimental 1 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 1 clinical development for the treatment of acne vulgaris.
ORG101- Experimental 1 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied for the treatment of acne vulgaris.
ORG101- Experimental 1 has one completed Phase 1 clinical trial registered under NCT05131373. This trial, titled "Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris," enrolled 38 participants in Germany and was a randomized, double-blind, placebo-controlled study.
Yes, ORG101- Experimental 1 is also known as ORI-A-ce001. The Phase 1 clinical trial NCT05131373, which studied the drug for acne vulgaris, used the name ORI-A-ce001 in its title. Both names refer to the same investigational small molecule being developed by Sanofi.