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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

12 Feb 2026 → ongoing

Decision date (initial)

2026-02-07

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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

Secondary objectives 1

1. To investigate the impact of anifriolumab therapy on the clinical course of patients with cutaneous lupus erythematosus

Conditions and MedDRA coding

cutaneous lupus erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Active lesions of histology proven cutaneous lupus erythematosus
2. age18 years or older
3. ability to understand and sign informed consent
4. 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
5. 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.

Exclusion criteria 10

1. Patients under legal protection
2. pregnancy
3. Positive test for HIV
4. Positive test for hepatitis C
5. 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
6. 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
7. Active malignancy (except local non-melanoma skin-cancer)
8. Concurrent enrolment in another clinical study with an investigational product
9. 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
10. Prior receipt of anifrolumab shorter than 12 weeks before first dosage of the IP.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. changes in inflammatory cell composition and gene expression profiles in skin and blood samples.

Secondary endpoints 1

1. the impact of anifriolumab therapy on the clinical course of patients with cutaneous lupus erythematosus.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Dermatology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Dermatology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications