TARGeted therapy using intradermal injection of ETanercept to treat Discoid Lupus Erythematosus (TARGET-DLE)

Phase 1

• Conditions: Discoid lupus erythematosus; MedDRA version: 18.0Level: LLTClassification code 10013072Term: Discoid lupus erythematosusSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-001602-33-GB
• Lead Sponsor: The University of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Study Completion: 2017-12-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

(i) Adults aged 18-65 years old.
(ii) Have at least one active DLE lesion, either diagnosed by skin biopsy or confirmation by Consultant Dermatologist/Rheumatologist.
(iii) Patients with DLE only and SLE patients with DLE are included.
(iv) Have refractory disease to an anti-malarial at 3 months as assessed by the Dermatologist/Rheumatologist.
(v) Patients receiving anti-malarials must have been receiving them for at least 3 months prior to Screening, with a stable dose regimen for at least 28 days (±1 day) prior to Baseline (the first study drug administration)
(vi) Ability to provide an informed consent.
(vii) All male and female patients biologically capable of having children must agree to use a reliable method of contraception for the duration of the study and for a period of 3 weeks after their final dose of study drug. Acceptable methods of contraception are surgical sterilisation, oral, implantable or injectable hormonal methods, intrauterine devices or barrier contraceptives.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

(i) Any prior treatment with TNF-blockade therapies.
(ii) Intramuscular or intra-dermal corticosteroid within 28 days of the Screening visit.
(iii) Oral steroid of greater than 10mg prednisolone daily, or change in oral steroid dose within 28 days prior to the Baseline Visit.
(iv) A change in the dose of other immunosuppressant including methotrexate, azathioprine and mycophenolate mofetil within 28 days (±1 day) prior to Baseline Visit.
(v) Concomitant therapies with any alkylating agents (e.g. cyclophosphamide, chlorambucil), other immunosuppressant including sulfasalazine and leflunomide, other biological agent particularly anakinra and abatacept and other experimental drug. If patients are on any of these, they need to be off therapies for at least 28 days prior to Baseline Visit to allow for washout.
(vi) Evidence of an immunosuppressive state, including an active HIV infection, agammaglobulinaemia, T-cell deficiencies or Human T cell Lymphotrophic Virus Type 1 (HTLV-1).
(vii) Chronic active infection such as hepatitis B or hepatitis C and tuberculosis. Patients with latent tuberculosis may be included if treated with chemoprophylaxis for at least 2 months before starting the study and to continue chemoprophylaxis for a total of 6 months
(viii) History of cancer within the last 5 years except for squamous or basal cell skin carcinoma that has been completely excised and treated cervical carcinoma in situ.
(ix) Demyelinating diseases.
(x) Moderate to severe heart failure based on New York Heart Association (NYHA) functional class III and IV.
(xi) Pregnancy.
(xii) Breastfeeding.
(xiii) Planned surgery within the study period which is expected to require omission of study medication of 28 days or more.
(xiv) Receipt of live attenuated vaccine within 28 days prior to the Baseline Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified