Healthy VolunteersPhase 13NCT01428297
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
A Phase 1 study testing BPR277 ointment and BPR277 in people with Healthy Volunteers and Atopic Dermatitis, run by Novartis Pharmaceuticals at 4 sites in 2 countries.
Trial summary
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Atopic Dermatitis, Netherton Syndrome
- What is being tested?
- BPR277 ointment and BPR277
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2011to Feb 2014
- 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
- Part 1 Healthy volunteers
- Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
- Part 2 Patients with atopic dermatitis:
- Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
- Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
- History of involvement of the skin creases
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- Personal history of asthma or hay fever
- History of generally dry skin in the past year
- Onset before age of 2 years
- Visible flexural dermatitis
- Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
- Part 3 Patients with Netherton Syndrome:
- Patients with Netherton syndrome, male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
- Confirmed diagnosis of Netherton syndrome (SPINK5 mutation or LEKTI deficiency in the skin).
- Minimum total lesional sign score NS (TLSS-NS) of 5-9 for two selected target areas at baseline. The TLSS-NS values need to be similar between the two areas at baseline.
Who cannot join
- Part 1 Healthy volunteers :
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- Part 2 Patients with atopic dermatitis:
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
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- Pregnant or nursing (lactating) women.
- Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
- Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
- Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
- Part 3 Patients with Netherton Syndrome:
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
- Use of topical prescription treatment within 2 week prior to initial dosing of study drug.
- Recent previous treatment with systemic treatment. A washout period will be required for such patients to be eligible to participate in the trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Novartis Investigative Site
Fargo, North Dakota, 58104
Novartis Investigative Site
New Haven, Connecticut, 06519
Novartis Investigative Site
St Louis, Missouri, 63104
Netherlands1 site
Novartis Investigative Site
Utrecht, The Netherlands, 3508 GA
About this study
Official title: A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
- Conditions
- Healthy Volunteers, Atopic Dermatitis, Netherton Syndrome
- Being tested
- BPR277 ointment (controlled application), Placebo (Vehicle), BPR277 ointment, BPR277
- Keywords
- Atopic dermatitis, Eczema, Skin Diseases, Eczematous, Netherton syndrome, Skin Diseases, Genetic, BPR277
- Medical subject headings
- Dermatitis, Atopic, Netherton Syndrome, Eczema, Skin Diseases, Eczematous, Skin Diseases, Genetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPR277 ointment (controlled application)Drug
Placebo (Vehicle)Drug
BPR277 ointmentDrug
Placebo (Vehicle)Drug
BPR277Drug
Placebo (Vehicle)Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A and B, BPR277 and Placebo (vehicle) | Experimental | Not described Receives: Drug: BPR277 ointment (controlled application); Drug: Placebo (Vehicle) |
| Part 2 BPR277 | Experimental | Not described Receives: Drug: BPR277 ointment |
| Part 2 Placebo (vehicle) | Placebo comparator | Not described Receives: Drug: Placebo (Vehicle) |
| Part 3 BPR277 and Placebo (vehicle) | Experimental | Not described Receives: Drug: BPR277; Drug: Placebo (Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
Measured: 2-4 weeks
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area
Measured: 4 weeks
Secondary outcomes (1)
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428297
- Sponsor's protocol ID
- CBPR277X2101
- Other IDs
- 2011-000917-38
- Acronym
- 3
- Status last verified
- Feb 2015
- First submitted
- 19 Aug 2011
- Last updated
- 8 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome
- ClinicalTrials.gov ID
- NCT01428297
- Acronym / sponsor ID
- 3 / CBPR277X2101
- Conditions
- Healthy Volunteers, Atopic Dermatitis, Netherton Syndrome
- Keywords
- Atopic dermatitis, Eczema, Skin Diseases, Eczematous, Netherton syndrome, Skin Diseases, Genetic, BPR277
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Sep 2011 (estimated)
- 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.
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A and B, BPR277 and Placebo (vehicle) | Experimental | Drug: BPR277 ointment (controlled application), Drug: Placebo (Vehicle) |
| Part 2 BPR277 | Experimental | Drug: BPR277 ointment |
| Part 2 Placebo (vehicle) | Placebo comparator | Drug: Placebo (Vehicle) |
| Part 3 BPR277 and Placebo (vehicle) | Experimental | Drug: BPR277, Drug: Placebo (Vehicle) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part 1 Healthy volunteers
- Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
- Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
- Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
- Diagnosis of at least moderate atopic dermatitis by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline total lesional sign score (TLSS)
Key exclusion criteria (17 listed)
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
- History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| BPR277 ointment (controlled application) | Drug | Cohort A and B, BPR277 and Placebo (vehicle) |
| Placebo (Vehicle) | Drug | Cohort A and B, BPR277 and Placebo (vehicle) |
| BPR277 ointment | Drug | Part 2 BPR277 |
| Placebo (Vehicle) | Drug | Part 2 Placebo (vehicle) |
| BPR277 | Drug | Part 3 BPR277 and Placebo (vehicle) |
| Placebo (Vehicle) | Drug | Part 3 BPR277 and Placebo (vehicle) |
Primary outcome
Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry.
Time frame: 2-4 weeks
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change in Total Lesional Signs Score at the treated skin area
Time frame: 4 weeks
1 secondary outcome
Part 2 and 3: Patients with Atopic Dermatitis / Netherton syndrome: Change for each sign comprising the total lesional signs score at the treated skin area
Time frame: 4 weeks
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 8 Dec 2020.
- Results for CBPR277X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 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 BPR277 ointment and BPR277 in people with Healthy Volunteers and Atopic Dermatitis, run by Novartis Pharmaceuticals at 4 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 15 inclusion and 17 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 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Netherlands. 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?
Systemic and local tolerability of BPR277 ointment, as measured by change in local tolerability score, number of adverse events and clinically significant changes in standard hematology, blood chemistry. (time frame: 2-4 weeks). The study lists 2 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 8 Dec 2020.