Secukinumab for Treatment of Atopic Dermatitis

NCT02594098 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GCO 15-1486CAIN457AUS02T
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; extrinsic atopic dermatitis; intrinsic atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Fold-Change in Epidermal Thickness of Lesional Skin

  Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline

  at Week 16

Secondary Outcomes (13)

• Fold-Change in K16 Expression of Lesional Skin

  at Week 16

• Number of Patients With SCORAD-50

  Week 4, Week 16, Week 32, Week 52

• Number of Patients Who Achieve EASI-50 Score

  Week 4, Week 16, Week 32, Week 52

• Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1

  Week 16, Week 32, Week 52

• Percentage Change From Baseline in SCORAD Score

  at Week 16

Study Arms (2)

Secukinumab

EXPERIMENTAL

Secukinumab (300 mg) via subcutaneous injection using 2 prefilled syringes

Drug: Secukinumab

Placebo

PLACEBO COMPARATOR

Placebo via subcutaneous injection using 2 prefilled syringes

Drug: Placebo

Interventions

Secukinumab DRUG

At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.

Secukinumab

Placebo DRUG

At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Novartis: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Emma Guttman
• Organization: Icahn School of Medicine at Mount Sinai

emma.guttman@mountsinai.org

212-241-9728

Study Officials

• Emma Guttman, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 2, 2015
• Study Start: November 1, 2015
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)