NCT01831466

A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.

Completed Phase 2 Results posted Last updated 26 October 2015

What this trial tests

Phase 2 trial testing tofacitinib ointment 20 mg/g in Psoriasis Vulgaris in 476 participants. Completed in 1 September 2014.

Timeline

1 May 2013

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	476
Start date	1 May 2013
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	54 locations across United States, Canada, Denmark, Poland

Drugs / interventions tested

• tofacitinib ointment 20 mg/g — full drug profile →
• tofacitinib ointment 10 mg/g — full drug profile →
• placebo ointment (vehicle)
• tofacitinib ointment 20 mg/g — full drug profile →
• tofacitinib ointment 10 mg/g — full drug profile →
• placebo ointment (vehicle)

Conditions studied

• Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →
• Psoriasis — all drugs for Psoriasis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Psoriasis Vulgaris or Psoriasis. 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.

• Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12
  Time frame: Baseline, Week 12
  Clinical signs of plaque psoriasis (erythema \[E\], induration \[I\], and scaling \[S\]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total aver
• Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8
  Time frame: Baseline, Week 8
  Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole num

Sponsor's own description

The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.

Publications & conference data

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

1. Type I/II cytokines, JAKs, and new strategies for treating autoimmune diseases.
   Schwartz DM, Bonelli M, Gadina M, O'Shea JJ. · · 2016 · cited 474× · PMID 26633291 · DOI 10.1038/nrrheum.2015.167
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. 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
4. 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
5. Tyrosine Kinases in Autoimmune and Inflammatory Skin Diseases.
   Szilveszter KP, Németh T, Mócsai A. · · 2019 · cited 102× · PMID 31447854 · DOI 10.3389/fimmu.2019.01862
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 inhibitors: treatment efficacy and safety profile in patients with psoriasis.
   Hsu L, Armstrong AW. · · 2014 · cited 88× · PMID 24883332 · DOI 10.1155/2014/283617
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