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NCT05263505

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Terminated Phase 2 Results posted Last updated 7 November 2023
What this trial tests

Phase 2 trial testing Baricitinib 2 MG [Olumiant] in Mucous Membrane Pemphigoid in 2 participants. Terminated before completion.

Timeline
21 February 2022
Primary endpoint
11 September 2023
11 September 2023

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment2
Start date21 February 2022
Primary completion11 September 2023
Estimated completion11 September 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Mucous Membrane Pemphigoid or Cicatrizing Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Response Primary · 8 weeks

Treatment response of ocular inflammation based on conjunctival injection measured by ophthalmologic exam of the palpebral conjunctiva. Each eye is divided into quadrants and each quadrant is scored from 0 (white and quite) to 3 (severe). The score will be the sum of all 4 quadrants for a total score of 0-12 for each eye. A clinically meaningful response will be defined as a ≥30% reduction in the total score for both eyes.

GroupValue95% CI
Baricitinib1
Antiproliferative0

Adverse events — posted to ClinicalTrials.gov

Time frame: Averse events were recorded for 2 weeks for the participant in the standard of care arm and 8 months for the participant on the baricitinib arm.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baricitinib
Serious: 1/1 (100%)
Deaths: 0/1
Antiproliferative
Serious: 1/1 (100%)
Deaths: 0/1

Serious adverse events (2 terms)

ReactionSystemBaricitinibAntiproliferative
AnaphylaxisRespiratory, thoracic and mediastinal disorders
MalignancyNeoplasms benign, malignant and unspecified (incl cysts and polyps)

Most-reported serious reactions: Anaphylaxis, Malignancy.

Data from ClinicalTrials.gov NCT05263505 adverse events section.

Sponsor's own description

Ocular mucous membrane pemphigoid (MMP) is an autoimmune, scarring conjunctivitis that can lead to vision loss and permanent disability. It is a rare disorder with an estimated incidence of 1 in 60,000. There are currently no FDA-approved medications for the treatment of mucous membrane pemphigoid, highlighting a clear unmet need. At present, moderate to severe disease requires off-label use of potent immunosuppressive agents, such as oral anti-proliferatives (methotrexate, azathioprine, and mycophenolate), rituximab (RTX) or cyclophosphamide (CyC). Recently, Janus kinase (JAK) inhibition with baricitinib or tofacitinib been reported to be successful in one case of ocular MMP. This is a randomized, single-masked, two-arm study of baricitinib vs anti-proliferatives for ocular MMP.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting type 2 inflammation in bullous pemphigoid: current and emerging therapeutic approaches.
    Toh WH, Lee HE, Chen CB. · · 2023 · cited 7× · PMID 37614956 · DOI 10.3389/fmed.2023.1196946
  2. Tyrosine kinase signaling pathways as therapeutic targets in autoimmune subepidermal blistering skin diseases (pemphigoid diseases).
    Vikár S, Mócsai A. · · 2026 · PMID 41909698 · DOI 10.3389/fimmu.2026.1767876
  3. Autoimmune Bullous Diseases: Therapeutic Update.
    Kasperkiewicz M, van Beek N, Schmidt E. · · 2026 · PMID 41729378 · DOI 10.1007/s40265-026-02292-3

Verify or expand the search:

Other recruiting trials for Mucous Membrane Pemphigoid

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05263505.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing