Authorised Therapeutic use (Phase IV) cutaneous lupus erythematosus

The effect of anifrolumab on cutaneous lupus erythematosus characterized by the change of the inflammatory infiltrate analyzed by immunohistochemistry, spatial transcriptomics and single-cell RNA- and TCR-sequencing as well as on the clinical outcome - an open label, single arm phase IV pilot study

EU CTIS ID: 2025-523133-26-00

What this study is testing

To investigate the impact of anifriolumab therapy on inflammatory cells in skin and blood of patients with cutaneous lupus erythematosus

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Active lesions of histology proven cutaneous lupus erythematosus
  • age18 years or older
  • ability to understand and sign informed consent
  • adequate contraception: females of childbearing potential must use 2 effective methods of avoiding pregnancy, one of which is a barrier method, from screening until 12 weeks after the final dose of investigational product unless the subject is surgically sterile (ie bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy).Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
  • Meets all of the following TB criteria: (a) No history of active TB prior to any Screening visit (b) No history of latent TB prior to initial Screening visit, with the exception of latent TB with documented completion of appropriate treatment Note: Subjects with no history of latent TB prior to the initial Screening visit, but who are diagnosed with latent TB during screening, may be considered eligible if appropriate treatment is initiated prior to randomisation. Such subjects may be re-screened if necessary to allow for local guidelines on latent TB treatment initiation.

You likely can't join if

  • Patients under legal protection
  • Prior receipt of anifrolumab shorter than 12 weeks before first dosage of the IP.
  • pregnancy
  • Positive test for HIV
  • Positive test for hepatitis C
  • Confirmed positive test for hepatitis B serology for: (a) Hepatitis B surface antigen (HBsAg), OR (b) Hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantitation
See the full eligibility criteria
Who can join
  • Active lesions of histology proven cutaneous lupus erythematosus
  • age18 years or older
  • ability to understand and sign informed consent
  • adequate contraception: females of childbearing potential must use 2 effective methods of avoiding pregnancy, one of which is a barrier method, from screening until 12 weeks after the final dose of investigational product unless the subject is surgically sterile (ie bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy).Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
  • Meets all of the following TB criteria: (a) No history of active TB prior to any Screening visit (b) No history of latent TB prior to initial Screening visit, with the exception of latent TB with documented completion of appropriate treatment Note: Subjects with no history of latent TB prior to the initial Screening visit, but who are diagnosed with latent TB during screening, may be considered eligible if appropriate treatment is initiated prior to randomisation. Such subjects may be re-screened if necessary to allow for local guidelines on latent TB treatment initiation.
What rules you out
  • Patients under legal protection
  • Prior receipt of anifrolumab shorter than 12 weeks before first dosage of the IP.
  • pregnancy
  • Positive test for HIV
  • Positive test for hepatitis C
  • Confirmed positive test for hepatitis B serology for: (a) Hepatitis B surface antigen (HBsAg), OR (b) Hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantitation
  • Any severe herpesviridae infection at any time prior to Week 0 Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to Day 1
  • Active malignancy (except local non-melanoma skin-cancer)
  • Concurrent enrolment in another clinical study with an investigational product
  • A known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.