Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

NCT05048238 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: DAIT ALE11
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm, multi-site, proof-of-concept study that will evaluate the treatment of 10 participants with cutaneous lupus erythematosus (CLE) with Tofacitinib.

Conditions

Cutaneous Lupus

Keywords

Systematic Lupus Erythematosus; Lupus; Systemic Lupus; Cutaneous Lupus; Tofacitinib; Ultraviolet

Outcome Measures

Primary Outcomes (1)

• Change in Percentage of UVB-induced Apoptotic Epidermal Cells

  At Day 0 and Day 25, skin was exposed to 10-80 mJ/cm2 UVB irradiation. At Day 1 and Day 26, erythema levels were measured with a Chroma Meter at each dose site and in an unexposed section. Skin biopsies at Day 1 and Day 26 were taken at the unexposed site and at the minimal erythema dose (MED) at Day 1. The percentage of apoptotic epidermal cells were determined in each skin biopsy sample by TUNEL staining. The percentage of UVB-induced apoptotic cells is defined as the difference between the percentage of apoptotic epidermal cells in the UVB-exposed biopsy at the MED and percentage of apoptotic epidermal cells in the unexposed biopsy at the same visit. Change in percentage of UVB-induced apoptotic epidermal cells is calculated as the difference in the percentage of UVB-induced apoptotic cells at Day 26 and at Day 1.

  Day 1 (pre-treatment) to Day 26

Secondary Outcomes (8)

• Change in Minimal Erythema Dose (MED) Due to UVB

  Day 1 (pre-treatment) to Day 26

• Change in UVB-induced Expression of Inflammatory Genes in Skin Based on Enumeration of RNA Transcripts.

  Day 1 (pre-treatment) to Day 26

• Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score

  Day 0 (pre-treatment) to Day 25

• Change in CLASI Damage Score

  Day 0 (pre-treatment) to Day 25

• Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score

  Day 0 (pre-treatment) to Day 25

Study Arms (1)

Tofacinitib

EXPERIMENTAL

10 participants receiving 11 mg of Tofacitinib administered orally and daily, from Day 2 to Day 26

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

10 participants with Cutaneous lupus erythematosus (CLE). Consenting individuals meeting all entry criteria will undergo 25 days of treatment with tofacitinib (11 mg orally (PO) daily) with evaluation of UVB-mediated cutaneous apoptosis

Also known as: XELJANZ(R) XR

Tofacinitib

Eligibility Criteria

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

You may qualify if:

• Cutaneous lupus erythematosus based upon all of the following:
• a clinical diagnosis made by a rheumatologist or dermatologist of one of the following: acute cutaneous lupus erythematosus, subacute cutaneous lupus, or chronic cutaneous lupus erythematosus;
• active skin disease within 5 years prior to screening. Participants may have concomitant SLE.
• SLEDAI-2K score ≤4 (clinical criteria only, excludes all laboratory criteria) for all participants regardless of whether they have concomitant SLE.
• If taking oral corticosteroids, the dose must be ≤ 10 mg daily of prednisone (or equivalent), stable dose for at least 4 weeks, and not anticipated to change over the course of the study.
• If taking oral anti-malarial medications, the dose(s) must be ≤ 100 mg daily for quinacrine or/and ≤ 400 mg daily for hydroxychloroquine, stable for at least 6 months, and not anticipated to change over the course of the study.
• If taking oral or subcutaneous methotrexate, the dose must be ≤ 25 mg weekly, stable for at least 4 weeks, and not anticipated to change over the course of the study.
• If taking oral leflunomide, the dose must be ≤ 20 mg daily, stable for at least 4 weeks, and not anticipated to change over the course of the study.
• If taking oral mycophenolate mofetil (MMF) or mycophenolic acid, the dose must be equivalent to ≤ 3000 mg of MMF daily, stable for at least 4 weeks, and not anticipated to change over the course of the study.
• Adults 18 to 65 years of age at screening.
• All participants and/or their sexual partners who engage in sexual activity that could lead to pregnancy must be willing to use complete abstinence or an FDA-regulated form of contraception for the duration of the study and for at least one month after discontinuation of study drug to prevent pregnancy. Highly effective birth control methods include, but are not limited to, hormonal contraception, an intrauterine device, or surgical options. Periodic abstinence and withdrawal are not acceptable methods of birth control.

You may not qualify if:

• Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
• Current or recent history, within the last year, of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurologic disease or significant impairment that might negatively impact the participant's ability to participate or that may put a participant at increased risk.
• Potential active nephritis and/or urinary tract infection at screening, defined as any one of the following determined at screening unless otherwise specified:
• \>10 RBCs /hpf,
• \>5 WBCs /hpf with either positive nitrites or greater than a trace leukocyte esterase,
• Signs or symptoms of a urinary tract infection,
• For individuals with no history of nephritis: Urine protein (mg/dL): creatinine (mg/dL) ratio (Pr/Cr)\>0.5 at screening or a Pr/Cr level that has exceeded 1.0 in the prior 12 months,
• For individuals with a history of nephritis: A rise in Pr/Cr of \>0.5 over the prior 3-6 months prior to screening.
• History of severe gastrointestinal narrowing or strictures.
• Medically confirmed history of diverticulitis or chronic, ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis, or other symptomatic, lower GI conditions that might predispose a participant to perforations.
• History of thrombosis, pulmonary embolism, or antiphospholipid syndrome.
• History of any one of the following anti-phospholipid antibodies:
• Positive lupus anticoagulant test, or
• Anti-β2-glycoprotein I IgG ELISA titer ≥ 40 GPL, or
• Anti-cardiolipin IgG ELISA titer ≥ 40 GPL.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

Ann Arbor, Michigan, 48109, United States

Location

Related Links

• Autoimmunity Centers of Excellence (ACE)
• National Institute of Allergy and Infectious Diseases (NIAID)
• Division of Allergy, Immunology, and Transplantation (DAIT)

MeSH Terms

Interventions

tofacitinib

Limitations and Caveats

The protocol specified inferential statistics for the primary and some secondary endpoints. Given the small number of participants enrolled, no statistical testing was performed, and only descriptive statistics are presented.

Results Point of Contact

• Title: Director, Clinical Research Operations Program
• Organization: DAIT/NIAID

DAITClinicalTrialsGov@niaid.nih.gov

301-594-7669

Study Officials

• Joanne M Kahlenberg, M.D., Ph.D.

  University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 17, 2021
• Study Start: September 30, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 29, 2024
• Last Updated: August 22, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of the study
• Access Criteria: Data will be sent to ImmPort, but not made available to the public, due to small sample size of study.

Locations

US (2)