Atopic DermatitisPhase 2NCT02594098
Secukinumab for Treatment of Atopic Dermatitis
A Phase 2 study testing Secukinumab in people with Atopic Dermatitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Secukinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 30 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
- Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
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- Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
- Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Who cannot join
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
- Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
Show all 9Show fewer
- Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis.
- Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
- Patients with stable chronic asthma, treated with inhaled corticosteroids, will be allowed to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families.
In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.
Read the detailed description
This is a randomized, double-blind, pilot study of a total of 44 subjects with AD (22 with intrinsic and 22 with extrinsic AD) consisting of 2 phases. Subjects will be randomized (2:1) to either receive secukinumab 300 mg or placebo via subcutaneous injection using 2 prefilled syringes.
- Conditions
- Atopic Dermatitis
- Being tested
- Secukinumab, Placebo
- Keywords
- Atopic dermatitis, extrinsic atopic dermatitis, intrinsic atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecukinumabDrug
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
PlaceboDrug
At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab | Experimental | Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes Receives: Drug: Secukinumab |
| Placebo | Placebo comparator | Placebo via subcutaneous injection using 2 prefilled syringes Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold-Change in Epidermal Thickness of Lesional Skin
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
Measured: at Week 16
Secondary outcomes (13)
Fold-Change in K16 Expression of Lesional Skin
Epidermal hyperplasia assessed using change in the epidermal proliferation marker Ki67 at week 16 as compared to baseline. Staining quantification was performed with ImageJ 1.42
Measured: at Week 16
Number of Patients With SCORAD-50
The proportion of patients who achieve an improvement of 50% or greater from their Baseline objective SCORAD up to week 52. SCORing Atopic Dermatitis (SCORAD) -The intensity part of the SCORAD index consists of six items: erythema, edema⁄papulation, excoriations, lichenification, oozing⁄crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms.
Measured: Week 4, Week 16, Week 32, Week 52
Number of Patients Who Achieve EASI-50 Score
The proportion of patients who achieve an improvement of 50% or greater from their Baseline EASI score up to week 52. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity.
Measured: Week 4, Week 16, Week 32, Week 52
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
The proportion of patients who achieve a score of "clear-0" or "almost clear-1" in the static IGA score at Week 16 as compared to Baseline. The static IGA score represents an overall static evaluation of dermatitis, performed by the investigator at each visit. It utilizes a scale of 6-points; total scale ranging from 0 (clear) to 5 (very severe disease).
Measured: Week 16, Week 32, Week 52
Percentage Change From Baseline in SCORAD Score
Percentage change in SCORAD scores at Week 16 as compared to baseline. SCORing Atopic Dermatitis (SCORAD) full score is 0-103, with higher score indicating more symptoms.
Measured: at Week 16
Percentage Change From Baseline in EASI Scores
Percentage change in EASI scores at Week 16 as compared to baseline. Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity.
Measured: at Week 16
Fold-Change in Elafin/Pi3 Level From Baseline
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of elafin/Pi3 at week 16 as compared to baseline
Measured: at Week 16
Fold-Change in CCL20 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CCL20 at week 16 as compared to baseline.
Measured: at Week 16
Fold-Change in CXCL1 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CXCL1 at week 16 as compared to baseline.
Measured: at Week 16
Fold-Change in S100A7 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of S100A7 at week 16 as compared to baseline.
Measured: at Week 16
Fold-Change in A8 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A8 at week 16 as compared to baseline
Measured: at Week 16
Fold-Change in A9 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A9 at Week 16 as compared to baseline.
Measured: at Week 16
Fold-Change in A12 Level
Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline
Measured: at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Emma.Guttman, Icahn School of Medicine at Mount Sinai
- Investigators
- Emma Guttman, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594098
- Sponsor's protocol ID
- GCO 15-1486
- Other IDs
- CAIN457AUS02T
- Status last verified
- May 2019
- First submitted
- 30 Oct 2015
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy and Safety of Secukinumab in the Treatment of Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02594098
- Acronym / sponsor ID
- GCO 15-1486
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, extrinsic atopic dermatitis, intrinsic atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2015
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at least 4-7% of adults and 15-25% of children to be affected, with one third of patients having severe disease. It results in very itchy, red, swollen, and cracked skin. Scratching worsens the symptoms and causes the skin to become thickened over time. Patients with atopic dermatitis have an increased risk of skin infections, and many also develop hay fever or asthma. Atopic dermatitis can cause significant distress to both patients and their families.
In this study, the aim is to assess the effects of a new treatment called secukinumab in patients with atopic dermatitis. A total of 30 patients will be included in the study, which will run for a total of 52 weeks.
Detailed description
This is a randomized, double-blind, pilot study of a total of 44 subjects with AD (22 with intrinsic and 22 with extrinsic AD) consisting of 2 phases. Subjects will be randomized (2:1) to either receive secukinumab 300 mg or placebo via subcutaneous injection using 2 prefilled syringes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secukinumab | Experimental | Drug: SecukinumabSecukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo via subcutaneous injection using 2 prefilled syringes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
Key exclusion criteria (9 listed)
- Male or female subject at least 18 years of age
- If female, the subject is not pregnant or nursing
- Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- Chronic (>6 months) atopic dermatitis (intrinsic disease with IgE levels that are below 200, and extrinsic disease with IgE levels above 200).
- Moderate to severe AD (SCORAD index ≥25, and IGA index≥3).
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 |
|---|---|---|
| SecukinumabAt Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study. | Drug | Secukinumab |
| PlaceboAt Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study. | Drug | Placebo |
Primary outcome
Fold-Change in Epidermal Thickness of Lesional Skin
Time frame: at Week 16
Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline
13 secondary outcomes
Fold-Change in K16 Expression of Lesional Skin
Time frame: at Week 16
Number of Patients With SCORAD-50
Time frame: Week 4, Week 16, Week 32, Week 52
Number of Patients Who Achieve EASI-50 Score
Time frame: Week 4, Week 16, Week 32, Week 52
Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1
Time frame: Week 16, Week 32, Week 52
Percentage Change From Baseline in SCORAD Score
Time frame: at Week 16
Percentage Change From Baseline in EASI Scores
Time frame: at Week 16
Fold-Change in Elafin/Pi3 Level From Baseline
Time frame: at Week 16
Fold-Change in CCL20 Level
Time frame: at Week 16
Fold-Change in CXCL1 Level
Time frame: at Week 16
Fold-Change in S100A7 Level
Time frame: at Week 16
Fold-Change in A8 Level
Time frame: at Week 16
Fold-Change in A9 Level
Time frame: at Week 16
Fold-Change in A12 Level
Time frame: at Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Emma Guttman, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Secukinumab in people with Atopic Dermatitis, run by Icahn School of Medicine at Mount Sinai 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 9 inclusion and 9 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 12 Jun 2019. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fold-Change in Epidermal Thickness of Lesional Skin (time frame: at Week 16). 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 12 Jun 2019.