GingivitisPhase 1/2NCT03694444
A Study of the C3 Complement Inhibitor AMY-101 in Adults With Gingivitis
A Phase 1/2 study testing AMY-101 and Water for injection in people with Gingivitis, run by Amyndas Pharmaceuticals S.A. at 1 site in United States.
Trial summary
A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with gingivitis. The study is a 3-month randomized, double-blind, split-mouth study of adults with existing chronic periodontal inflammation determined by the level of gingival index and bleeding on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- AMY-101 and Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 30 Oct 2020
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 18-65 years old.
- Equal to or greater than 18 natural teeth present (excluding third molars).
- Generalized periodontal inflammation determined by modified gingival index and percent bleeding on probing (MGI≥2.0, BOP ≥ 40%).
- In good general health as evidenced by medical history.
- For women of reproductive potential, use of licensed hormonal contraception or barrier methods or abstinence for at least 1 month prior to screening and agreement to use such a method during study participation.
- For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with partner.
Who cannot join
- Presence of orthodontic appliances (including fixed lingual retainer).
- A soft or hard tissue tumor of the oral cavity.
- Carious lesions requiring immediate treatment.
- Participation in any other clinical study within 30 days of screening or during the study.
- Antibiotic therapy within the last 30 days.
- Chronic use (≥3 times/week) of anti-inflammatory medications [e.g., non-steroidal anti-inflammatory drugs (NSAIDs), steroids]. Low dose (<325 mg) aspirin is allowed.
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- Immune compromised subjects (e.g., subjects with HIV infection, neutropenia, complement deficiency, etc.).
- Any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues, such as diabetes (irrespective of level of control), rheumatoid arthritis, Crohn's disease, nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g., warfarin [Coumadin] etc.), ongoing cancer treatment either with radiation or chemotherapy.
- Involvement in the planning or conduct of the study.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or interfere with interpretation of the subject's study results.
- Pregnancy or lactation.
- Uncontrolled chronic diseases (e.g., kidney disease, COPD, pulmonary fibrosis, Hepatitis C)
- Autoimmune disorders (Down's Syndrome, Sjogren's Disease, Psoriasis, Chediak-Higashi Syndrome)
- Conditions requiring antibiotic prophylaxis.
- Periodontal therapy within the past one year.
- Gross tooth decay, as determined by the investigator.
- Periodontal or dental abscesses.
- Root fragments, pericoronitis, endo-perio lesions.
- Use of cigarettes or other tobacco products (including e-cigarette or recreational drug use) within 1 year before the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Clinical Trial to Assess the Safety and Efficacy of C3 Inhibitor AMY-101, in Adults With Gingivitis
A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with gingivitis.
The study is a 3-month randomized, double-blind, split-mouth study of adults with existing chronic periodontal inflammation determined by the level of gingival index and bleeding on probing. The primary endpoint of change in gingival index will be evaluated at 21, 28 and 90 days after initial treatment (baseline treatment). Subjects will also be followed at Day 3, 7, 14, 21, 28 and 90 for safety evaluations. Change in bleeding on probing plaque index, pocket depth, clinical attachment level and GCF levels of pro-inflammatory cytokines and complement factors will be assessed as secondary outcome measures. Composition of subgingival biofilm will be assessed as an exploratory endpoint.
Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. After clinical assessments and sample collection at baseline, both test and placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14.
- Conditions
- Gingivitis
- Being tested
- AMY-101, Water for injection
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMY-101Drug
C3 complement inhibitor
Water for injectionOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AMY-101 treatment | Active comparator | Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. In the AMY-101 treatment arm after clinical assessments and sample collection at baseline, test treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. Receives: Drug: AMY-101 |
| Placebo | Placebo comparator | Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. In the placebo arm, after clinical assessments and sample collection at baseline, placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. Receives: Other: Water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean gingival index (MGI)
Measured: Assessed at 28 days after initial treatment
Secondary outcomes (11)
Gingival inflammation
Measured: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Ulceration in the oral cavity
Measured: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Oral infections
Measured: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Changes in mean gingival index
Measured: Assessed at Days 21 and 90
Changes in mean bleeding on probing (BOP)
Measured: Assessed at baseline and 21, 28 and 90 days
Changes in mean probing depth (PD)
Measured: Assessed at baseline and 21, 28 and 90 days
Number of sites with PD greater or equal to 5 mm
Measured: Assessed at baseline and 21, 28 and 90 days
Changes in mean clinical attachment level (CAL)
Measured: Assessed at baseline and 21, 28 and 90 days
Changes in plaque index (PI)
Measured: Assessed at baseline and 21, 28 and 90 days
Levels of gingival crevicular fluid (GCF)
Measured: Assessed at baseline and 21, 28 and 90 days
Levels of proinflammatory mediators in the GCF
Measured: Assessed at baseline and 21, 28 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start22 Jul 2019
- Primary completion30 Aug 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amyndas Pharmaceuticals S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694444
- Sponsor's protocol ID
- AMY-101/perio1
- Status last verified
- Feb 2021
- First submitted
- 23 Sep 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hasturk H, Hajishengallis G; Forsyth Institute Center for Clinical and Translational Research staff; Lambris JD, Mastellos DC, Yancopoulou D. Phase IIa clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation. J Clin Invest. 2021 Dec 1;131(23):e152973. doi: 10.1172/JCI152973.
PubMed 34618684Hajishengallis G, Hasturk H, Lambris JD; Contributing authors. C3-targeted therapy in periodontal disease: moving closer to the clinic. Trends Immunol. 2021 Oct;42(10):856-864. doi: 10.1016/j.it.2021.08.001. Epub 2021 Sep 2.
PubMed 34483038
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Clinical Trial to Assess the Safety and Efficacy of C3 Inhibitor AMY-101, in Adults With Gingivitis
- ClinicalTrials.gov ID
- NCT03694444
- Acronym / sponsor ID
- AMY-101/perio1
- Conditions
- Gingivitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Amyndas Pharmaceuticals S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 3 Oct 2018 (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.
A Phase 2a Clinical Trial to Assess the Safety and Efficacy of Complement 3 Inhibitor Analog, AMY-101, in Adults with gingivitis.
The study is a 3-month randomized, double-blind, split-mouth study of adults with existing chronic periodontal inflammation determined by the level of gingival index and bleeding on probing. The primary endpoint of change in gingival index will be evaluated at 21, 28 and 90 days after initial treatment (baseline treatment). Subjects will also be followed at Day 3, 7, 14, 21, 28 and 90 for safety evaluations. Change in bleeding on probing plaque index, pocket depth, clinical attachment level and GCF levels of pro-inflammatory cytokines and complement factors will be assessed as secondary outcome measures. Composition of subgingival biofilm will be assessed as an exploratory endpoint.
Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. After clinical assessments and sample collection at baseline, both test and placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMY-101 treatment | Active comparator | Drug: AMY-101Subjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. In the AMY-101 treatment arm after clinical assessments and sample collection at baseline, test treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. |
| Placebo | Placebo comparator | Other: Water for injectionSubjects who meet inclusion criteria will be enrolled in the study and sites will be randomized to treatment groups (AMY-101 or placebo) in split mouth design. In the placebo arm, after clinical assessments and sample collection at baseline, placebo treatments will be administered to each of the interproximal papilla and will be repeated on Day 7 and 14. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 18-65 years old.
- Equal to or greater than 18 natural teeth present (excluding third molars).
- Generalized periodontal inflammation determined by modified gingival index and percent bleeding on probing (MGI≥2.0, BOP ≥ 40%).
Key exclusion criteria (19 listed)
- Presence of orthodontic appliances (including fixed lingual retainer).
- A soft or hard tissue tumor of the oral cavity.
- Carious lesions requiring immediate treatment.
- Participation in any other clinical study within 30 days of screening or during the study.
- Antibiotic therapy within the last 30 days.
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 |
|---|---|---|
| AMY-101C3 complement inhibitor | Drug | AMY-101 treatment |
| Water for injectionPlacebo | Other | Placebo |
Primary outcome
Change in mean gingival index (MGI)
Time frame: Assessed at 28 days after initial treatment
11 secondary outcomes
Gingival inflammation
Time frame: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Ulceration in the oral cavity
Time frame: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Oral infections
Time frame: Assessed at baseline and Days 3, 7, 14, 21, and 28.
Changes in mean gingival index
Time frame: Assessed at Days 21 and 90
Changes in mean bleeding on probing (BOP)
Time frame: Assessed at baseline and 21, 28 and 90 days
Changes in mean probing depth (PD)
Time frame: Assessed at baseline and 21, 28 and 90 days
Number of sites with PD greater or equal to 5 mm
Time frame: Assessed at baseline and 21, 28 and 90 days
Changes in mean clinical attachment level (CAL)
Time frame: Assessed at baseline and 21, 28 and 90 days
Changes in plaque index (PI)
Time frame: Assessed at baseline and 21, 28 and 90 days
Levels of gingival crevicular fluid (GCF)
Time frame: Assessed at baseline and 21, 28 and 90 days
Levels of proinflammatory mediators in the GCF
Time frame: Assessed at baseline and 21, 28 and 90 days
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 21 Feb 2021.
- Derived from this study: PubMed 34618684Hasturk H, Hajishengallis G; Forsyth Institute Center for Clinical and Translational Research staff; Lambris JD, Mastellos DC, Yancopoulou D. Phase IIa clinical trial of complement C3 inhibitor AMY-101 in adults with periodontal inflammation. J Clin Invest. 2021 Dec 1;131(23):e152973. doi: 10.1172/JCI152973.
- Derived from this study: PubMed 34483038Hajishengallis G, Hasturk H, Lambris JD; Contributing authors. C3-targeted therapy in periodontal disease: moving closer to the clinic. Trends Immunol. 2021 Oct;42(10):856-864. doi: 10.1016/j.it.2021.08.001. Epub 2021 Sep 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AMY-101 and Water for injection in people with Gingivitis, run by Amyndas Pharmaceuticals S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in mean gingival index (MGI) (time frame: Assessed at 28 days after initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03694444, which also lists 2 linked publications.
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 21 Feb 2021.