NCT03553823

Brief Summary

The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in controlling inflammation in psoriatic plaques that remain active despite treatment with the non-selective IL-23 inhibitor ustekinumab (blocker of p40 subunit, shared by IL-12 and IL 23).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_2

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 25, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

May 15, 2018

Results QC Date

January 21, 2021

Last Update Submit

October 7, 2021

Conditions

Chronic Plaque-type Psoriasis

Keywords

PsoriasisPlaque psoriasisSecukinumabSkin conditionskin diseaseitchingpsoriasis vulgarisimmune-mediated systemic diseaseskin lesionsscaly patchespapules

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2)

    Total clinical score: number (%) of subjects who responded at Week 16 (FAS)

    16 week

Study Arms (2)

secukinumab

EXPERIMENTAL

20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive

Procedure: Skin biopsies

Guselkumab

ACTIVE COMPARATOR

20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.

Procedure: Skin biopsies

Interventions

Skin biopsiesPROCEDURE

At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS ≥ 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline.

Guselkumabsecukinumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic plaque-type psoriasis considered inadequately controlled after treatment with ustekinumab according to the following criteria-:
  • Ustekinumab administered at a dose equal or higher than that on the label for at least 24 weeks. The last administration must be at least 12 weeks before randomization
  • absolute PASI score of 1-10 at Screening
  • Presence of at least 1 refractory skin plaque, defined by a TCS of at least 6 and severity score of at least 2 or 3 (moderate) for each individual item, with an area ≥ 10 cm2 at screening.

You may not qualify if:

  • Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline
  • Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at Baseline
  • Previous treatment with more than one TNFα inhibitor or with IL-17A (including secukinumab), IL-17R or IL-23 (including guselkumab) inhibitors
  • Use of other investigational drugs within 4 weeks before enrolment, or within a period of 5 half lives of enrollment/initiation of the study treatment, whichever is longer
  • Ongoing use of prohibited treatments (see Section 6.2.2)
  • Known immunosuppression (e.g., AIDS) at Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novartis Investigative Site

New Orleans, Louisiana, 70112, United States

Location

Novartis Investigative Site

East Windsor, New Jersey, 08520, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19140, United States

Location

Novartis Investigative Site

Dallas, Texas, 75230, United States

Location

Novartis Investigative Site

Verdun, Quebec, H4G 3E7, Canada

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bochum, 44791, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Halle, 06108, Germany

Location

Novartis Investigative Site

Hamburg, 22391, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Memmingen, 87700, Germany

Location

Novartis Investigative Site

Selters, 56242, Germany

Location

Related Publications (1)

  • Krueger J, Langley RG, Nigen S, Kasparek T, Di Comite G, Ortmann CE, Garcet S, Kolbinger F, Reich K. Secukinumab versus guselkumab in the complete resolution of ustekinumab-resistant psoriatic plaques: The ARROW study. Exp Dermatol. 2023 Oct;32(10):1834-1847. doi: 10.1111/exd.14828. Epub 2023 Jun 5.

    PMID: 37272375DERIVED

Related Links

MeSH Terms

Conditions

PsoriasisSkin DiseasesPruritus

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Analysis of biomarkers is delayed due to the global coronavirus pandemic of 2020, thus, the biomarker-related exploratory objectives were not evaluated in this present report; but will be presented in a voluntary future update.

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
novartis.email@novartis.com
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinded outcome assessor assessed subjects on each visit for target plaque TCS, PASI, IGA, BSA, ppIGA, PSSI, NAPS.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This was a 16-week, randomized, open-label, parallel-group, active-control study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

June 12, 2018

Study Start

January 14, 2019

Primary Completion

January 28, 2020

Study Completion

January 28, 2020

Last Updated

October 11, 2021

Results First Posted

February 25, 2021

Record last verified: 2021-10

Locations

CA(1)US(4)DE(9)