Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

NCT03568136 | Completed Phase 2

• 2 other identifiers: Secu_Trial2016-005181-57
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief Summary

The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall support the extension of the approval for Secukinumab from psoriasis to atopic dermatitis. The effectiveness of Secukinumab is determined on the reduction of the eczema score EASI 50 (Eczema Area and Severity Index, a tool to measure the severity of atopic dermatitis) at week 4.

Conditions

Dermatitis, Atopic; Eczema, Atopic; Neurodermatitis, Atopic

Keywords

neurodermatitis; moderate to severe inflammatory reaction of the skin; Skin and Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction in EASI

  Proportion of patients with a reduction of the eczema score EASI of at least 50%. The proportions are then compared between study arms.

  week 4 (visit 4)

Secondary Outcomes (10)

• Reduction of EASI

  baseline (day 1, visit 0) and End of Trial (Arm A week 12 / Arm B week 16)

• Reduction of EASI

  Arm A week 12 / Arm B week 16

• Reduction in SCORAD (Scoring atopic dermatitis)

  day 1, week 4 and Arm A week 12 / Arm B week 16

• Change in pruritus score (Visual Analogue Scale)

  day 1, week 4 and Arm A week 12 / Arm B week 16

• Change in IGA Score (5-point Investigator's Global Assessment)

  Arm A week 12 / Arm B week 16

Study Arms (2)

Treatment Arm A

EXPERIMENTAL

Patients in treatment arm A receive 300 mg Secukinumab administered as 2 subcutaneous injections of 150 mg (i.e. 2x 150 mg) at baseline day 1 and week 1, 2, 3, 4, 8, 12 and injections with placebo at week 5, 6, 7 and 16. For assessments of the study endpoints were followed up visits at week 20 and 24. Placebo will be administered as 2 subcutaneous injections.

Drug: Secukinumab 300 mg; Drug: Placebo

Treatment Arm B

PLACEBO COMPARATOR

Patients in treatment arm B receive placebo until visit 3 (week 3) and will switch to Secukinumab 300 mg s.c. up from visit 4 (week 4), visit 5, 6, 7, 8, 12 and16. For assessments of the study endpoints were followed up visits at week 20 and 24.

Drug: Secukinumab 300 mg; Drug: Placebo

Interventions

Secukinumab 300 mg DRUG

Solution for injection in pre-filled syringe

Also known as: COSENTYX ®

Treatment Arm A; Treatment Arm B

Placebo DRUG

Solution for injection in pre-filled syringe

Also known as: Placebo (for Secukinumab)

Treatment Arm A; Treatment Arm B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic dermatitis (intrinsic disease without IgE mediated sensitization defined by negative history and negative SX-1 CAP FEIA or extrinsic disease defined by positive history and / or positive SX-1 CAP FEIA),
• SCORAD index score ≥ 25,
• EASI ≥ 16,
• Male and female patients at the age of 18 to 85 years,
• Signed Informed Consent,
• Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed,
• 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:

• Other inflammatory skin disease than atopic dermatitis,
• Use of cyclosporine, azathioprine, mycophenolate \[wash-out period of 4 weeks\]; Phototherapy (PUVA, NB-UVB, UVA1; \[wash-out period of 2 weeks\]), Dupilumab (Dupixent®; \[wash-out period of 12 weeks\])
• Subjects expected to be exposed to an undue safety risk if participating in the trial including chronic infections,
• Contraindications of Secukinumab by label (i.e. approval for the treatment of psoriasis in the EU - refer to point 14 - 16 at the bottom of this section),
• Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial,
• Plans for administration of live vaccines during the study period,
• Chronic infection,
• Patients with instable chronic asthma,
• Any chronic inflammatory bowel disease (e.g. Crohn's disease),
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>10 mIU/mL),
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 20 weeks after stopping treatment. Effective contraception is defined as either:
• Barrier method: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (where available). Spermicides alone are not a barrier method of contraception and should not be used alone,
• The following methods are considered more effective than the barrier method and are also acceptable:
• Total abstinence: When this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence \[e.g. calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception),
• Female sterilization: have had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment,

Sponsors & Collaborators

• GWT-TUD GmbH: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (5)

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Carl Gustav Carus University Hospital, Department of Dermatology

Dresden, 01307, Germany

Location

SRH Wald-Klinikum Gera, Center for Clinical Studies

Gera, 07548, Germany

Location

Hannover Medical School, Department for Dermatology, Allergy and Venereology

Hanover, 30625, Germany

Location

SIBAmed Studienzentrum GmbH & Co KG

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Neurodermatitis; Skin and Connective Tissue Diseases

Interventions

secukinumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Stefan Beissert, Prof. Dr.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 26, 2018
• Study Start: September 18, 2018
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: May 3, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)