A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome (3)
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ClinicalTrials.gov Identifier: NCT01428297 |
Recruitment Status :
Completed
First Posted : September 2, 2011
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers Atopic Dermatitis Netherton Syndrome | Drug: BPR277 ointment (controlled application) Drug: Placebo (Vehicle) Drug: BPR277 ointment Drug: BPR277 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A and B, BPR277 and Placebo (vehicle) |
Drug: BPR277 ointment (controlled application) Drug: Placebo (Vehicle) |
Experimental: Part 2 BPR277 |
Drug: BPR277 ointment |
Placebo Comparator: Part 2 Placebo (vehicle) |
Drug: Placebo (Vehicle) |
Experimental: Part 3 BPR277 and Placebo (vehicle) |
Drug: BPR277 Drug: Placebo (Vehicle) |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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
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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
- 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.
Exclusion Criteria:
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.
- 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.

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): NCT01428297
United States, Connecticut | |
Novartis Investigative Site | |
New Haven, Connecticut, United States, 06519 | |
United States, Missouri | |
Novartis Investigative Site | |
Saint Louis, Missouri, United States, 63104 | |
United States, North Dakota | |
Novartis Investigative Site | |
Fargo, North Dakota, United States, 58104 | |
Netherlands | |
Novartis Investigative Site | |
Utrecht, The Netherlands, Netherlands, 3508 GA |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Clinical Disclosure Office, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01428297 |
Other Study ID Numbers: |
CBPR277X2101 2011-000917-38 |
First Posted: | September 2, 2011 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | February 2015 |
Atopic dermatitis Eczema Skin Diseases, Eczematous |
Netherton syndrome Skin Diseases, Genetic BPR277 |
Dermatitis, Atopic Netherton Syndrome Dermatitis Eczema Syndrome Disease Pathologic Processes Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Abnormalities, Multiple Congenital Abnormalities Ichthyosiform Erythroderma, Congenital Ichthyosis Skin Abnormalities Infant, Newborn, Diseases Keratosis |