Back to resultsSafety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris (OREA)
Primary Purpose
Acne Vulgaris
Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
ORG101 - Experimental 1
ORG101PL - Placebo 1
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, C. acnes, vaccine, dose escalation, first in human, FIH, skin microbiome, placebo
Eligibility Criteria
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 contraception during the study
- Subject with a clinical diagnosis of moderate facial acne vulgaris (grade 3 on a 5-grade IGA scale) at Baseline Visit
- Subject must have a maximum of 40 non-inflammatory acne lesions (open and closed comedones) and between a minimum of 20 and a maximum of 70 inflammatory acne lesions (papules and pustules) and a maximum of 1 nodulocystic lesion (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline Visit
- Negative Covid test at Baseline Visit
Exclusion Criteria:
- Subject who is pregnant, lactating or is planning a pregnancy during the study period
- Subject who has active nodulocystic acne, acne conglobata, acne fulminans, secondary acne or other forms of acne
- Subject who has more than one facial nodules/cysts (where nodule/cyst is defined as an inflammatory lesion greater than or equal to 0.5 cm in size with or without cystic changes)
- Subject who has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the Investigational Medicinal Product (IMP) or requires use of interfering topical, systemic, or surgical therapy
- Subject with excessive facial hair, facial skin disorders, skin reactions that may interfere with the study assessments in the Investigator's opinion or skin infection
- History of Guillain-Barré-Syndrome
- Subject who has used any acne-affecting treatment without an appropriate washout period
- Subject who receives active or passive vaccination within 30 days prior to Baseline Visit Initiation or change of hormonal contraceptive use within 12 weeks prior to Screening Visit
Sites / Locations
- Universitäts-Hautklinik TübingenRecruiting
- Universitätsklinikum FrankfurtRecruiting
- Fachklinik Bad BentheimRecruiting
- Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)Recruiting
- CentroDermRecruiting
- UKSH, Campus LübeckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental 1
Placebo 1
Arm Description
C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections
Outcomes
Primary Outcome Measures
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
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)
Incidence of AEs and SAEs
Number of participants with AEs or SAEs as assessed by physical examination
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
Clinically significant change from the baseline in laboratory data as compared to placebo
Change from the baseline in vital signs
Clinically significant change from the baseline in vital signs as compared to placebo
Change from the baseline in ECG
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Change from the baseline in physical examination
Clinically significant change from the baseline in physical examination, as compared to placebo
Secondary Outcome Measures
Immunogenicity assessment
The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups
Change in inflammatory lesion counts
Absolute and percentage change from Baseline in the number of inflammatory acne lesions
Change in non-inflammatory lesion counts
Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
Investigator's global assessment (IGA) - change from Baseline
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with at least one-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) [scores: 0-4; 0=clear, 4=severe]
Assessment of subjects' treatment acceptability
Treatment acceptability, as assessed by the pre-defined questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05131373
Brief Title
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
Acronym
OREA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
June 8, 2023 (Anticipated)
Study Completion Date
June 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This trial investigates the safety and tolerability of three different doses of a C. acnes vaccine (ORI-A-ce001) in subjects with acne vulgaris.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris, C. acnes, vaccine, dose escalation, first in human, FIH, skin microbiome, placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Sequential cohorts (dose escalation)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental 1
Arm Type
Experimental
Arm Description
C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Description
Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections
Intervention Type
Drug
Intervention Name(s)
ORG101 - Experimental 1
Intervention Description
C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals
Intervention Type
Drug
Intervention Name(s)
ORG101PL - Placebo 1
Intervention Description
Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals
Primary Outcome Measure Information:
Title
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
Description
Number of participants with AEs as assessed by electronic diary (eDiary) and/or PI assessment, and compared to placebo
Time Frame
7 days following each vaccination
Title
Incidence of AEs and serious adverse events (SAEs)
Description
Incidence of AEs and SAEs
Time Frame
through study completion, an average of 9 months
Title
Number of participants with AEs or SAEs as assessed by physical examination
Description
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)
Time Frame
through study completion, an average of 9 months
Title
Change from the baseline in laboratory data
Description
Clinically significant change from the baseline in laboratory data as compared to placebo
Time Frame
through study completion, an average of 9 months
Title
Change from the baseline in vital signs
Description
Clinically significant change from the baseline in vital signs as compared to placebo
Time Frame
through study completion, an average of 9 months
Title
Change from the baseline in ECG
Description
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Time Frame
Weeks 0 and 36
Title
Change from the baseline in physical examination
Description
Clinically significant change from the baseline in physical examination, as compared to placebo
Time Frame
through study completion, an average of 9 months
Secondary Outcome Measure Information:
Title
Immunogenicity assessment
Description
The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups
Time Frame
Weeks 0, 4, 8, 12, 16, 24 and 36
Title
Change in inflammatory lesion counts
Description
Absolute and percentage change from Baseline in the number of inflammatory acne lesions
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Title
Change in non-inflammatory lesion counts
Description
Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Title
Investigator's global assessment (IGA) - change from Baseline
Description
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Title
Investigator's global assessment (IGA) - percentage of subjects with improvement
Description
Percentage of subjects with at least one-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) [scores: 0-4; 0=clear, 4=severe]
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Title
Assessment of subjects' treatment acceptability
Description
Treatment acceptability, as assessed by the pre-defined questionnaire
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 contraception during the study
Subject with a clinical diagnosis of moderate facial acne vulgaris (grade 3 on a 5-grade IGA scale) at Baseline Visit
Subject must have a maximum of 40 non-inflammatory acne lesions (open and closed comedones) and between a minimum of 20 and a maximum of 70 inflammatory acne lesions (papules and pustules) and a maximum of 1 nodulocystic lesion (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline Visit
Negative Covid test at Baseline Visit
Exclusion Criteria:
Subject who is pregnant, lactating or is planning a pregnancy during the study period
Subject who has active nodulocystic acne, acne conglobata, acne fulminans, secondary acne or other forms of acne
Subject who has more than one facial nodules/cysts (where nodule/cyst is defined as an inflammatory lesion greater than or equal to 0.5 cm in size with or without cystic changes)
Subject who has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the Investigational Medicinal Product (IMP) or requires use of interfering topical, systemic, or surgical therapy
Subject with excessive facial hair, facial skin disorders, skin reactions that may interfere with the study assessments in the Investigator's opinion or skin infection
History of Guillain-Barré-Syndrome
Subject who has used any acne-affecting treatment without an appropriate washout period
Subject who receives active or passive vaccination within 30 days prior to Baseline Visit Initiation or change of hormonal contraceptive use within 12 weeks prior to Screening Visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ira G Federspiel, PhD
Phone
+436763699216
Email
ira.federspiel@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zrinka Ivezic-Schoenfeld, PhD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Universitäts-Hautklinik Tübingen
City
Tübingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Hahn, Dr. med.
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
State/Province
Hesse
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Pinter, Dr. med.
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
North Rhine-Westphalia
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Tsianakas, PD Dr.med.
Facility Name
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
City
Bochum
State/Province
North Rhine-Westphalia
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Falk Bechara, Prof.Dr.med.
Facility Name
CentroDerm
City
Wuppertal
State/Province
North Rhine-Westphalia
ZIP/Postal Code
42287
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Dirschka, Prof.Dr.med.
Facility Name
UKSH, Campus Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diamant Thaci, Prof.Dr.med.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
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