NCT03002649 (STIR) is a Phase 1 clinical trial of Tofacitinib in Dermatomyositis, sponsored by Johns Hopkins University.

Who is sponsoring NCT03002649?

NCT03002649 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT03002649?

Interventions in NCT03002649: Tofacitinib.

What condition does NCT03002649 study?

NCT03002649 studies Dermatomyositis.

Is NCT03002649 still recruiting?

NCT03002649 is currently completed. Last updated 5 November 2020.

Last reviewed 2020-11-05 · How we verify

NCT03002649: STIR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Tofacitinib in Refractory Dermatomyositis (STIR): Proof of Concept, Open-Label Study of 10 Patients

Completed Phase 1 Last updated 5 November 2020

What this trial tests

Phase 1 trial testing Tofacitinib in Dermatomyositis in 10 participants. Completed in 30 September 2020.

Timeline

1 January 2017

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 January 2017
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across United States

Drugs / interventions tested

Tofacitinib (tofacitinib) — full drug profile →

Conditions studied

Dermatomyositis — all drugs for Dermatomyositis →

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of participants who achieve International Myositis Assessment and Clinical Studies (IMACS) Definition of Improvement (DOI)
Time frame: Up to 12 weeks
IMACS DOI is 3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the manual muscle testing)

Sponsor's own description

The purpose of this study is to obtain preliminary data regarding the safety and efficacy of Janus kinase (JAK) inhibitor, tofacitinib, in adults with active, treatment-refractory dermatomyositis.

Publications & conference data

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

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
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
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
JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
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
Type I Interferons in Systemic Autoimmune Diseases: Distinguishing Between Afferent and Efferent Functions for Precision Medicine and Individualized Treatment.
Chasset F, Dayer JM, Chizzolini C. · · 2021 · cited 34× · PMID 33986670 · DOI 10.3389/fphar.2021.633821
Myositis-Related Interstitial Lung Diseases: Diagnostic Features, Treatment, and Complications.
Shappley C, Paik JJ, Saketkoo LA. · · 2019 · cited 28× · PMID 31984206 · DOI 10.1007/s40674-018-0110-6

Verify or expand the search:

Other trials of Tofacitinib

Trials testing the same drug.

NCT07530367 — A Phase III Randomized Controlled Trial Evaluating the Efficacy and Safety of Tofacitinib Combined With Imatinib in Pati · Phase 3 · not yet recruiting
NCT07406204 — Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) · Phase 4 · not yet recruiting
NCT07343635 — The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined · NA · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT07297069 — Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial · Phase 2 · not yet recruiting

Other recruiting trials for Dermatomyositis

Currently open trials in the same condition.

NCT06672822 — Intralesional Injection of STS in Treatment of Calcinosis · Phase 2 · recruiting
NCT06698796 — A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies · Phase 3 · recruiting
NCT06732674 — Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases · NA · recruiting
NCT06686524 — Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refracto · Phase 1 · recruiting
NCT07037472 — Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treat · NA · recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03002649 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 5 November 2020

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/NCT03002649.

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