Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus

NCT02656082 | Completed Phase 2 DMC

• 2 other identifiers: RR15/1142015-001602-33
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Etanercept which is given through intradermal injection is effective in the treatment of discoid lupus erythematosus (DLE). The investigators also would like to develop new tests to measure skin inflammation by scanning the affected skin using optical coherence tomography (OCT), thermography and laser doppler imaging (LDI) and taking photographs of the rash (to be done before and after treatment). If the findings from these new tests are similar to the ones from taking a sample of skin (biopsy), then the latter (which is an invasive test) can be avoided.

Conditions

Lupus Erythematosus, Discoid; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Chronic Cutaneous

Keywords

Discoid lupus erythematosus; Intradermal injection of etanercept

Outcome Measures

Primary Outcomes (1)

• The proportion of patients who achieve a reduction in the modified limited Score of Activity and Damage in Discoid Lupus Erythematosus (SADDLE) score by 20% of the baseline score in the index lesion

  A modified SADDLE score will be used; limited to only one index lesion and the efficacy is judged based on total score in activity component only.

  At Week 12

Secondary Outcomes (18)

• Change in Physician's Visual Analogue Scale (VAS) for global assessment of disease activity from Baseline

  At Week 12

• Change in daily oral prednisolone dose from Baseline

  At Week 12

• Change in Dermatology Life Quality Index (DLQI) from Baseline

  At Week 12

• Change in Participant's VAS for global health assessment from Baseline

  At Week 12

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From Baseline to 15 weeks

Study Arms (1)

Etanercept

EXPERIMENTAL

Intradermal injection of etanercept. The dosage is determined based on discoid lesion radius. Weekly injection up to 12 weeks.

Drug: Etanercept

Interventions

Etanercept DRUG

Treatment with etanercept is intended for remission induction of DLE only and not for maintenance purpose.

Also known as: Enbrel

Etanercept

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years old.
• Have at least one active DLE lesion, either diagnosed by skin biopsy or confirmation by Dermatologist/ Rheumatologist.
• Patients with DLE only and SLE patients with DLE are included.
• Have refractory disease to an anti-malarial for at least 3 months as assessed by Dermatologist/Rheumatologist.
• 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)
• Ability to provide an informed consent.
• 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.

You may not qualify if:

• Any prior treatment with TNF-blockade therapies.
• Intramuscular or intra-dermal corticosteroid within 28 days of the Screening visit.
• Corticosteroid of greater than 10mg prednisolone daily equivalent, or change in oral steroid dose within 28 days prior to Baseline Visit.
• A change in the dose of other immunosuppressant including methotrexate, azathioprine and mycophenolate mofetil within 28 days (±1 day) prior to Baseline Visit.
• 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.
• Evidence of an immunosuppressive state, including an active HIV infection, agammaglobulinaemias, T-cell deficiencies or Human T cell Lymphotrophic Virus Type 1 (HTLV-1).
• 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.
• 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.
• Demyelinating diseases.
• Moderate to severe heart failure based on New York Heart Association (NYHA) functional class III and IV.
• Pregnancy.
• Breastfeeding.
• Planned surgery within the study period which is expected to require omission of study medication of 28 days or more.
• Receipt of live attenuated vaccine within 28 days prior to the Baseline Visit.

Sponsors & Collaborators

• University of Leeds: lead
• National Institute for Health Research, United Kingdom: collaborator
• Pfizer: collaborator
• Clinical Trials Research Unit, Leeds: collaborator

Study Sites (1)

Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid; Lupus Erythematosus, Cutaneous

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Paul Emery, MD FMedSci

  University of Leeds

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 14, 2016
• Study Start: February 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

GB (1)