NCT03026504

Baricitinib in Relapsing Giant Cell Arteritis

Completed Phase 2 Results posted Last updated 8 April 2022

What this trial tests

Phase 2 trial testing Baricitinib in Arteritis, Giant Cell in 15 participants. Completed in 12 April 2021.

Timeline

9 March 2017

Primary endpoint
12 April 2021

12 April 2021

Quick facts

Lead sponsor	Matthew J Koster
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	9 March 2017
Primary completion	12 April 2021
Estimated completion	12 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Baricitinib (baricitinib) — full drug profile →

Conditions studied

• Arteritis, Giant Cell — all drugs for Arteritis, Giant Cell →

Sponsor

Matthew J Koster

Who can join

50 and older, any sex, with Arteritis, Giant Cell. 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.

Adverse Events Primary · 52 weeks

The percentage of subjects who experienced greater than or equal to one adverse event

Group	Value	95% CI
Baricitinib Therapy	93

Giant Cell Arteritis (GCA) Relapse Secondary · 24 weeks, 52 weeks

The number of subjects to experience relapse of GCA at 24 weeks and 52 weeks. As defined as: Presence of ESR ≥30 mm/hour and/or CRP ≥10 mg/L and the presence of at least one of the following: * Unequivocal cranial symptoms of GCA. * Unequivocal symptoms of PMR. * Other features judged by the clinician to be consistent with GCA or PMR (eg, fever of unknown origin, unexplained weight loss, fatigue/ malaise, etc) for which no other aetiology was identified as causational.

24 Weeks

Group	Value	95% CI
Baricitinib Therapy	1

52 Weeks

Group	Value	95% CI
Baricitinib Therapy	1

Erythrocyte Sedimentation Rate (ESR) Secondary · week 0, week 24, week 52

ESR is a blood test that detects and monitors inflammation in the body. The normal range is 0 to 22 mm/hr for men and 0 to 29 mm/hr for women.

Week 0

Group	Value	95% CI
Baricitinib Therapy	7	6 – 17

Week 24

Group	Value	95% CI
Baricitinib Therapy	13	7 – 19

Week 52

Group	Value	95% CI
Baricitinib Therapy	10	5 – 17

C Reactive Protein (CRP) Secondary · week 0, week 24, week 52

C-reactive protein is a substance produced by the liver in response to inflammation. Normal blood CRP levels are below 3.0 mg/L.

Week 0

Group	Value	95% CI
Baricitinib Therapy	3.4	NA – 6.9

Week 24

Group	Value	95% CI
Baricitinib Therapy	NA	NA – NA

Week 52

Group	Value	95% CI
Baricitinib Therapy	NA	NA – 3.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study, approximately 64 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baricitinib Therapy

Serious: 1/15 (7%)

Deaths: 0/15

Serious adverse events (1 terms)

Reaction	System	Baricitinib Therapy
thrombocytopenia	Blood and lymphatic system disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Baricitinib Therapy
Infection not requiring antibiotics	Infections and infestations	—
Nausea	Gastrointestinal disorders	—
Infection requiring antibiotics	Infections and infestations	—
Edema limbs - leg	General disorders	—
Fatigue	General disorders	—
Diarrhea	Gastrointestinal disorders	—

Most-reported serious reactions: thrombocytopenia.

Data from ClinicalTrials.gov NCT03026504 adverse events section.

Sponsor's own description

This study will evaluate the safety and effectiveness of baricitinib in the treatment of giant cell arteritis. All participants will be taking prednisone at the start of the study. The prednisone will be reduced according to a standardized tapering schedule while participants continue to take one tablet of baricitinib daily for 52 weeks.

Publications & conference data

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

1. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
   Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
2. 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
3. Signal Transducer and Activator of Transcription (STATs) Proteins in Cancer and Inflammation: Functions and Therapeutic Implication.
   Loh CY, Arya A, Naema AF, Wong WF, et al · · 2019 · cited 241× · PMID 30847297 · DOI 10.3389/fonc.2019.00048
4. 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
5. 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
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. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
   Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
8. 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