Atopic DermatitisPhase 1NCT04612062
A First-in-Human Study of CEE321 in Adult Subjects
A Phase 1 study testing CEE321 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
Trial summary
Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CEE321
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 27 Feb 2020to 16 May 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
- Healthy male and female subjects aged ≥18 and ≤ 65 years
- Able to comply with requirement of domiciliation at the investigational site
Who cannot join
- Subjects with a history of hypertrophic scars or keloids.
- Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
- Women of childbearing potential defined as all women physiologically capable of becoming pregnant.
- History of drug or alcohol abuse within the 12 months prior to dosing
- Key inclusion Criteria for Atopic Dermatitis Subjects (Part B)
- Written informed consent
Show all 14Show fewer
- Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
- Adult male or female subjects aged ≥18 and ≤ 65 years with confirmed clinical diagnosis of atopic dermatitis (AD)
- Subjects with a history of hypertrophic scars or keloids.
- Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
- Women of childbearing potential defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
- History of drug or alcohol abuse within the 3 months prior to dosing
- Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity
- Clinical significant medical condition, including psychiatric condition, which in the Investigator's opinion may interfere with safety of subjects, study objectives or adherence to the protocol.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Novartis Investigative Site
Baltimore, Maryland, 21225
Novartis Investigative Site
Glendale, California, 91206
About this study
Official title: A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects
Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- CEE321
- Keywords
- First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEE321Drug
Also called CEE321 0.2% (3 mg/cm2) topical cream b.i.d.
CEE321 administered to all subjects
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects (Part A) | Experimental | CEE321 0.2% (3 mg/cm2) topical cream b.i.d. Receives: Drug: CEE321 |
| Atopic Dermatitis (Part B) | Experimental | CEE321 0.2% (3 mg/cm2) topical cream b.i.d. Receives: Drug: CEE321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
Measured: adverse events recorded during study
Secondary outcomes (1)
Plasma trough concentration of CEE321
Measured: day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start27 Feb 2020
- Primary completion16 May 2021
- Study completion16 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a FIH study of CEE321 in Adult Healthy Subjects (Part A) and Subjects with Atopic Dermatitis (Part B). Enrollment started with Healthy Subjects in Feb 2020. The protocol was amended Jul 2020 to include Atopic Dermatitis (AD) Subjects (Part B).
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612062
- Sponsor's protocol ID
- CCEE321A12101
- Other IDs
- jRCT2031200317
- Status last verified
- Oct 2022
- First submitted
- 27 Oct 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study to Determine Safety, Tolerability and Systemic Exposure of Topically Applied CEE321 Cream in Adult Subjects
- ClinicalTrials.gov ID
- NCT04612062
- Acronym / sponsor ID
- CCEE321A12101
- Conditions
- Atopic Dermatitis
- Keywords
- First-in-Human, Healthy Volunteers, Atopic Dermatitis, CEE321, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 16 May 2021 (actual)
- Study completion
- 16 May 2021 (actual)
- First posted
- 2 Nov 2020 (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.
Open label, non-randomized, uncontrolled, First-in-Human Phase 1 Study in Healthy Subjects and Subjects with Atopic Dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a FIH study of CEE321 in Adult Healthy Subjects (Part A) and Subjects with Atopic Dermatitis (Part B). Enrollment started with Healthy Subjects in Feb 2020. The protocol was amended Jul 2020 to include Atopic Dermatitis (AD) Subjects (Part B).
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects (Part A) | Experimental | Drug: CEE321CEE321 0.2% (3 mg/cm2) topical cream b.i.d. |
| Atopic Dermatitis (Part B) | Experimental | Drug: CEE321CEE321 0.2% (3 mg/cm2) topical cream b.i.d. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Able to communicate well with the investigator to understand and comply with the requirements of the study, including skin biopsies
- Healthy male and female subjects aged ≥18 and ≤ 65 years
- Able to comply with requirement of domiciliation at the investigational site
Key exclusion criteria (14 listed)
- Subjects with a history of hypertrophic scars or keloids.
- Any infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals and/or hospitalization, isolation, quarantine within 4 weeks prior to first treatment
- Women of childbearing potential defined as all women physiologically capable of becoming pregnant.
- History of drug or alcohol abuse within the 12 months prior to dosing
- Key inclusion Criteria for Atopic Dermatitis Subjects (Part B)
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 |
|---|---|---|
| CEE321Also: CEE321 0.2% (3 mg/cm2) topical cream b.i.d.CEE321 administered to all subjects | Drug | Atopic Dermatitis (Part B), Healthy Subjects (Part A) |
Primary outcome
Number of subjects with adverse events
Time frame: adverse events recorded during study
1 secondary outcome
Plasma trough concentration of CEE321
Time frame: day 15
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 28 Oct 2022.
- jRCTLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEE321 in people with Atopic Dermatitis, run by Novartis Pharmaceuticals at 3 sites in 2 countries.
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 4 inclusion and 14 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Japan. 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. 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?
Number of subjects with adverse events (time frame: adverse events recorded during study). 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 28 Oct 2022.