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

NCT02656082

Last updated date
Study Location
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital
Leeds, , LS7 4SA, United Kingdom
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Discoid Lupus Erythematosus, Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Discoid Lupus Erythematosus, Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus ErythematosusTargeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus
NCT02656082
  1. Leeds,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Targeted Therapy Using Intradermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus
Official Title  ICMJE A Single Arm, Phase II Open Label Trial to Investigate the Efficacy and Safety of Intra-dermal Injection of Etanercept for Remission Induction in Discoid Lupus Erythematosus
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.

Detailed Description

There is an unmet need for new therapies to control inflammation in discoid lupus erythematosus (DLE). A significant proportion of DLE patients (with or without systemic lupus erythematosus (SLE)) are resistant to conventional therapies and DLE may be exacerbated by B cell depletion therapy.There is no clinical guideline or algorithm on how to manage patients with DLE who have refractory disease to the first line agents, anti-malarials. If left untreated, uncontrolled inflammation will lead to permanent disfiguring and irreversible scar to the patient, thus pose a major cosmetic issue and significantly impair the quality of life.

Targeted therapy based on immunopathogenesis is an attractive approach and tumour necrosis factor (TNF) is implicated in the pathogenesis of DLE. However, systemic administration of TNF blockers has been associated with induction of pathogenic autoantibodies that may render SLE worse or progression from DLE only to SLE. TNF blockers have been administered using the intra-dermal injection route in other TNF-mediated diseases and appear similarly safe and effective to systemic administration.

Another issue is the problem with outcome measures as skin disease is particularly heterogenous and many instruments rely on subjective assessment which may be difficult even in the hands of experts.

The TARGET-DLE trial will address these problems by: (i) administering a TNF blocker, etanercept using the intra-dermal route, which will provide local concentration to neutralise TNF in tissue while minimises the effect to systemic immunity and (ii) measuring tissue response using the existing outcome measure; the modified limited Score of Activity and Damage in DLE (SADDLE) as well as new objective measures such as skin biopsy, optical coherence tomography (OCT), thermography and laser Doppler imaging (LDI).

Data from this study may be used to power a definitive randomised controlled trial should the primary end point be achieved.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Cutaneous
  • Lupus Erythematosus, Chronic Cutaneous
Intervention  ICMJE Drug: Etanercept
Treatment with etanercept is intended for remission induction of DLE only and not for maintenance purpose.
Other Name: Enbrel
Study Arms  ICMJE Experimental: Etanercept
Intradermal injection of etanercept. The dosage is determined based on discoid lesion radius. Weekly injection up to 12 weeks.
Intervention: Drug: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656082
Other Study ID Numbers  ICMJE RR15/114
2015-001602-33 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuzaiful Md Yusof, University of Leeds
Study Sponsor  ICMJE University of Leeds
Collaborators  ICMJE
  • National Institute for Health Research, United Kingdom
  • Pfizer
  • Clinical Trials Research Unit, Leeds
Investigators  ICMJE
Study Chair:Paul Emery, MD FMedSciUniversity of Leeds
PRS Account University of Leeds
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP