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ORG101 - Experimental 1

Phase 1

Acne Vulgaris | Small molecule | Dermatology |Sanofi|Last Updated: Jan 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05131373Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne VulgarisPHASE1 COMPLETED 38 — — Sep 28, 2021Nov 27, 2023Jan 24, 20246 Germany
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Study Endpoints
Primary Endpoints
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
7 days following each vaccination

Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo

Incidence of AEs and serious adverse events (SAEs)
Through study completion, an average of 9 months

Incidence of AEs and SAEs

Number of participants with AEs or SAEs as assessed by physical examination
Through study completion, an average of 9 months

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)

Change from the baseline in laboratory data
Through study completion, an average of 9 months

Clinically significant change from the baseline in laboratory data as compared to placebo

Change from the baseline in vital signs
Through study completion, an average of 9 months

Clinically significant change from the baseline in vital signs as compared to placebo

Change from the baseline in ECG
Weeks 0 and 36

Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo

Change from the baseline in physical examination
Through study completion, an average of 9 months

Clinically significant change from the baseline in physical examination, as compared to placebo

Secondary Endpoints
Immunogenicity assessment
Weeks 0, 4, 8, 12, 16, 24 and 36
Change in inflammatory lesion counts
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Change in non-inflammatory lesion counts
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental 1EXPERIMENTALC. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
Placebo 1PLACEBO_COMPARATORPlacebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections
Interventions
NameTypeDescription
ORG101 - Experimental 1DRUGC. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals
ORG101PL - Placebo 1DRUGInjection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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...

Countries:Germany
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