NCT02535689

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Completed Phase 1 Last updated 9 August 2018

What this trial tests

Phase 1 trial testing Tofacitinib in Systemic Lupus Erythematosus in 34 participants. Completed in 26 April 2018.

Timeline

28 August 2015

Primary endpoint
26 April 2018

26 April 2018

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	34
Start date	28 August 2015
Primary completion	26 April 2018
Estimated completion	26 April 2018
Sites	1 location across United States

Drugs / interventions tested

• Tofacitinib (tofacitinib) — full drug profile →
• Placebo

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Who can join

Adults 18 to 100, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Systemic lupus erythematosus (lupus) is an autoimmune disease that often involves many systems and organs of the body. Symptoms can include fever, joint pains, and rashes. Serious lupus can also damage organs like the kidneys, lungs, or brain. Drugs used for lupus can have serious side effects. Also, the drugs don t help some people. Researchers want to find new, more effective and safe treatments.

Objective:

To evaluate the safety and tolerability of the drug tofacitinib (study drug) in people with lupus.

Eligibility:

People ages 18 and older who have mild to moderate lupus and are not currently or haven t recently had certain lupus treatments.

Design:

Participants will be screened in another protocol.

Participants will have 7 five-hour visits over about 3 months. They will fill out multiple questionnaires. They will have tests, including:

* Physical exam
* Blood and urine tests
* ECG/EKG: Soft electrodes are stuck to the skin to monitor the heart.
* Optional SphygmoCor: Cuffs are attached to the arm and thigh to measure blood pressure and flow speed.
* Optional Endopat: A thimble-shaped cup is placed on the finger to measure blood flow. A cuff is put on the arm to measure blood pressure and flow.
* Optional CAVI: ECG electrodes are placed on both wrists, a microphone placed on the chest, and a blood pressure cuff placed on each arm and leg to measure blood pressure and velocity.

Participants will receive either the study drug or a placebo. They will take this twice a day by mouth for 56 days.

Participants will be contacted by phone 4 times....

Publications & conference data

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

1. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
   Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
2. JAK-inhibitors. New players in the field of immune-mediated diseases, beyond rheumatoid arthritis.
   Fragoulis GE, McInnes IB, Siebert S. · · 2019 · cited 223× · PMID 30806709 · DOI 10.1093/rheumatology/key276
3. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
   Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
4. Phase 1 double-blind randomized safety trial of the Janus kinase inhibitor tofacitinib in systemic lupus erythematosus.
   Hasni SA, Gupta S, Davis M, Poncio E, et al · · 2021 · cited 154× · PMID 34099646 · DOI 10.1038/s41467-021-23361-z
5. New Horizons in the Genetic Etiology of Systemic Lupus Erythematosus and Lupus-Like Disease: Monogenic Lupus and Beyond.
   Demirkaya E, Sahin S, Romano M, Zhou Q, et al · · 2020 · cited 98× · PMID 32151092 · DOI 10.3390/jcm9030712
6. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
   Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
7. The Role of Janus Kinase Signaling in Graft-Versus-Host Disease and Graft Versus Leukemia.
   Schroeder MA, Choi J, Staser K, DiPersio JF. · · 2018 · cited 82× · PMID 29289756 · DOI 10.1016/j.bbmt.2017.12.797
8. Signaling Pathways of Type I and Type III Interferons and Targeted Therapies in Systemic Lupus Erythematosus.
   Chyuan IT, Tzeng HT, Chen JY. · · 2019 · cited 62× · PMID 31450787 · DOI 10.3390/cells8090963