Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris (OREA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05131373 |
|
Recruitment Status :
Recruiting
First Posted : November 23, 2021
Last Update Posted : July 11, 2022
|
Sponsor:
Origimm Biotechnology GmbH
Information provided by (Responsible Party):
Origimm Biotechnology GmbH
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acne Vulgaris | Drug: ORG101 - Experimental 1 Drug: ORG101PL - Placebo 1 | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 38 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Sequential cohorts (dose escalation) |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | double-blind |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 28, 2021 |
| Estimated Primary Completion Date : | June 8, 2023 |
| Estimated Study Completion Date : | June 8, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Experimental 1
C. acnes vaccine in adjuvanted formulation will be administered in double-blind fashion in 3 single increasing doses given i.m.
|
Drug: ORG101 - Experimental 1
C. acnes vaccine Injection, 25 mcg, 75 mcg, 225 mcg, 4 single i.m. injections given in monthly intervals |
|
Placebo Comparator: Placebo 1
Placebo in adjuvanted formulation will be administered in double-blind fashion in single i.m. injections
|
Drug: ORG101PL - Placebo 1
Injection, sterile aqueous solution of aluminium hydroxide, 4 single i.m. injections given in monthly intervals |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Immunogenicity assessment [ Time Frame: Weeks 0, 4, 8, 12, 16, 24 and 36 ]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 [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 ]Absolute and percentage change from Baseline in the number of inflammatory acne lesions
- Change in non-inflammatory lesion counts [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 ]Absolute and percentage change from Baseline in the number of non-inflammatory acne lesions
- Investigator's global assessment (IGA) - change from Baseline [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 ]Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
- Investigator's global assessment (IGA) - percentage of subjects with improvement [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32 and 36 ]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 [ Time Frame: Week 16 ]Treatment acceptability, as assessed by the pre-defined questionnaire
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131373
Contacts
| Contact: Ira G Federspiel, PhD | +436763699216 | ira.federspiel@sanofi.com |
Locations
| Germany | |
| Universitäts-Hautklinik Tübingen | Recruiting |
| Tübingen, Baden-Wuerttemberg, Germany, 72074 | |
| Contact: Matthias Hahn, Dr. med. | |
| Universitätsklinikum Frankfurt | Recruiting |
| Frankfurt, Hesse, Germany, 60590 | |
| Contact: Andreas Pinter, Dr. med. | |
| Fachklinik Bad Bentheim | Recruiting |
| Bad Bentheim, North Rhine-Westphalia, Germany, 48455 | |
| Contact: Athanasios Tsianakas, PD Dr.med. | |
| Universitaetsklinikum der Ruhr-Universitaet Bochum (UKRUB) | Recruiting |
| Bochum, North Rhine-Westphalia, Germany, 44791 | |
| Contact: Falk Bechara, Prof.Dr.med. | |
| CentroDerm | Recruiting |
| Wuppertal, North Rhine-Westphalia, Germany, 42287 | |
| Contact: Thomas Dirschka, Prof.Dr.med. | |
| UKSH, Campus Lübeck | Recruiting |
| Lübeck, Schleswig-Holstein, Germany, 23538 | |
| Contact: Diamant Thaci, Prof.Dr.med. | |
Sponsors and Collaborators
Origimm Biotechnology GmbH
Investigators
| Study Director: | Zrinka Ivezic-Schoenfeld, PhD | Origimm Biotechnology GmbH |
Additional Information:
| Responsible Party: | Origimm Biotechnology GmbH |
| ClinicalTrials.gov Identifier: | NCT05131373 |
| Other Study ID Numbers: |
ORI-101-PAC |
| First Posted: | November 23, 2021 Key Record Dates |
| Last Update Posted: | July 11, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Origimm Biotechnology GmbH:
|
acne vulgaris C. acnes vaccine dose escalation |
first in human FIH skin microbiome placebo |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |