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NCT03553823: ARROW

Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab

Completed Phase 2 Results posted Last updated 11 October 2021
What this trial tests

Phase 2 trial testing Skin biopsies in Chronic Plaque-type Psoriasis in 40 participants. Completed in 28 January 2020.

Timeline
14 January 2019
Primary endpoint
28 January 2020
28 January 2020

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date14 January 2019
Primary completion28 January 2020
Estimated completion28 January 2020
Sites14 locations across Canada, United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Chronic Plaque-type Psoriasis. 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.

Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2) Primary · 16 week

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

GroupValue95% CI
Secukinumab12
Guselkumab8

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected for duration of study to week 16. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Secukinumab
Serious: 2/20 (10%)
Deaths: 0/20
Guselkumab
Serious: 1/20 (5%)
Deaths: 0/20

Serious adverse events (3 terms)

ReactionSystemSecukinumabGuselkumab
GastritisGastrointestinal disorders
CholelithiasisHepatobiliary disorders
PneumoniaInfections and infestations
Other adverse events (20 terms — click to expand)

ReactionSystemSecukinumabGuselkumab
NasopharyngitisInfections and infestations
GoutMetabolism and nutrition disorders
Dacryostenosis acquiredEye disorders
BronchitisInfections and infestations
ErysipelasInfections and infestations
Herpes zosterInfections and infestations
Postoperative wound infectionInfections and infestations
SepsisInfections and infestations
Vulvovaginal mycotic infectionInfections and infestations
Wound dehiscenceInjury, poisoning and procedural complications
Blood bilirubin increasedInvestigations
HyperglycaemiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Acute kidney injuryRenal and urinary disorders
BalanoposthitisReproductive system and breast disorders
AsthmaRespiratory, thoracic and mediastinal disorders
Dyshidrotic eczemaSkin and subcutaneous tissue disorders
EczemaSkin and subcutaneous tissue disorders
HyperhidrosisSkin and subcutaneous tissue disorders
MiliariaSkin and subcutaneous tissue disorders

Most-reported serious reactions: Gastritis, Cholelithiasis, Pneumonia.

Data from ClinicalTrials.gov NCT03553823 adverse events section.

Sponsor's own description

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).

Publications & conference data

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

  1. Phage Display Derived Monoclonal Antibodies: From Bench to Bedside.
    Alfaleh MA, Alsaab HO, Mahmoud AB, Alkayyal AA, et al · · 2020 · cited 194× · PMID 32983137 · DOI 10.3389/fimmu.2020.01986
  2. Safety of selective IL-23p19 inhibitors for the treatment of psoriasis.
    Crowley JJ, Warren RB, Cather JC. · · 2019 · cited 58× · PMID 31054215 · DOI 10.1111/jdv.15653
  3. Immune cells in the epithelial immune microenvironment of psoriasis: emerging therapeutic targets.
    Li L, Lu J, Liu J, Wu J, et al · · 2023 · cited 26× · PMID 38239345 · DOI 10.3389/fimmu.2023.1340677
  4. Secukinumab versus guselkumab in the complete resolution of ustekinumab-resistant psoriatic plaques: The ARROW study.
    Krueger J, Langley RG, Nigen S, Kasparek T, et al · · 2023 · cited 5× · PMID 37272375 · DOI 10.1111/exd.14828
  5. T Cell Immunosenescence in Inflammatory Skin Diseases: Pathogenesis and Therapeutic Targets.
    Liu C, Yang M, Xiao F, Zeng J. · · 2026 · PMID 42050386 · DOI 10.1111/acel.70527
  6. Genetic liability to psoriasis predicts severe disease outcomes.
    Saklatvala JR, Lessard S, Teder-Laving M, Thomas LF, et al · · 2025 · PMID 41408349 · DOI 10.1186/s13073-025-01561-2

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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/NCT03553823.

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