Acne VulgarisPhase 1OREANCT05131373
Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris
A Phase 1 study testing ORG101 - Experimental 1 in people with Acne Vulgaris and Acne, run by Sanofi Pasteur, a Sanofi Company at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris, Acne
- What is being tested?
- ORG101 - Experimental 1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 6 sitesGermany
- Study dates
- 28 Sep 2021to 27 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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: Participants are excluded from the study if any of the following criteria apply:
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Fachklinik Bad Bentheim
Bad Bentheim, North Rhine-Westphalia, 48455
Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB)
Bochum, North Rhine-Westphalia, 44791
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590
UKSH, Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Universitäts-Hautklinik Tübingen
Tübingen, Baden-Wurttemberg, 72074
CentroDerm
Wuppertal, North Rhine-Westphalia, 42287
About this study
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
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
- Acne Vulgaris, Acne
- Being tested
- ORG101 - Experimental 1, ORG101PL - Placebo 1
- Keywords
- acne vulgaris, C. acnes, vaccine, dose escalation, first in human, FIH, skin microbiome, placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORG101 - Experimental 1Drug
- acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals
ORG101PL - Placebo 1Drug
Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m. Receives: Drug: ORG101 - Experimental 1 |
| Placebo 1 | Placebo comparator | Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections Receives: Drug: ORG101PL - Placebo 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days following each vaccination
Incidence of AEs and serious adverse events (SAEs)
Incidence of AEs and SAEs
Measured: Through study completion, an average of 9 months
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)
Measured: Through study completion, an average of 9 months
Change from the baseline in laboratory data
Clinically significant change from the baseline in laboratory data as compared to placebo
Measured: Through study completion, an average of 9 months
Change from the baseline in vital signs
Clinically significant change from the baseline in vital signs as compared to placebo
Measured: Through study completion, an average of 9 months
Change from the baseline in ECG
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Measured: Weeks 0 and 36
Change from the baseline in physical examination
Clinically significant change from the baseline in physical examination, as compared to placebo
Measured: Through study completion, an average of 9 months
Secondary outcomes (6)
Immunogenicity assessment
The amount of vaccine-antigen-specific serum antibody titers (IgG), measured by ELISA, compared to placebo and compared among different treatment groups
Measured: Weeks 0, 4, 8, 12, 16, 24 and 36
Change in inflammatory lesion counts
Absolute and percentage change from Baseline in the number of inflammatory acne lesions
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Change in non-inflammatory lesion counts
Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Investigator's global assessment (IGA) - change from Baseline
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
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]
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Assessment of subjects' treatment acceptability
Treatment acceptability, as assessed by the pre-defined questionnaire
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start28 Sep 2021
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131373
- Sponsor's protocol ID
- ORI-101-PAC
- Other IDs
- VBE00004, U1111-1294-8125
- Acronym
- OREA
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2021
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05131373
- Acronym / sponsor ID
- OREA / ORI-101-PAC
- Conditions
- Acne Vulgaris, Acne
- Keywords
- acne vulgaris, C. acnes, vaccine, dose escalation, first in human, FIH, skin microbiome, placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: ORG101 - Experimental 1C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m. |
| Placebo 1 | Placebo comparator | Drug: ORG101PL - Placebo 1Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORG101 - Experimental 1C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals | Drug | Experimental 1 |
| ORG101PL - Placebo 1Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals | Drug | Placebo 1 |
Primary outcome
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 0 and 36
Clinically significant change from the baseline in electrocardiogram (ECG) as compared to placebo
Change from the baseline in physical examination
Time frame: Through study completion, an average of 9 months
Clinically significant change from the baseline in physical examination, as compared to placebo
6 secondary outcomes
Immunogenicity assessment
Time frame: Weeks 0, 4, 8, 12, 16, 24 and 36
Change in inflammatory lesion counts
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Change in non-inflammatory lesion counts
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Investigator's global assessment (IGA) - change from Baseline
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Investigator's global assessment (IGA) - percentage of subjects with improvement
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36
Assessment of subjects' treatment acceptability
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ORG101 - Experimental 1 in people with Acne Vulgaris and Acne, run by Sanofi Pasteur, a Sanofi Company at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of solicited and unsolicited local and/or systemic adverse events (AEs) (time frame: 7 days following each vaccination). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.