Last reviewed · How we verify

NCT00684593

A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)

Completed Phase 2 Results posted Last updated 5 February 2019
What this trial tests

Phase 2 trial testing Navarixin 10 mg in Psoriasis in 31 participants. Completed in 1 October 2007.

Timeline
1 June 2007
Primary endpoint
1 October 2007
1 October 2007

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment31
Start date1 June 2007
Primary completion1 October 2007
Estimated completion1 October 2007

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 70, any sex, with 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.

Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29 Primary · Baseline and Day 29

PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).

GroupValue95% CI
Navarixin-3.30± 15.05
Placebo-2.14± 13.26
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29 Secondary · Day 29

The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.

Score = 0 (worse)
GroupValue95% CI
Navarixin7
Placebo2
Score = 1 (unchanged)
GroupValue95% CI
Navarixin6
Placebo2
Score = 2 (slight improvement)
GroupValue95% CI
Navarixin8
Placebo4
Score = 3 (fair improvement)
GroupValue95% CI
Navarixin0
Placebo1
Score = 4 (good improvement)
GroupValue95% CI
Navarixin0
Placebo0
Score = 5 (excellent improvement)
GroupValue95% CI
Navarixin0
Placebo0
Score = 6 (cleared)
GroupValue95% CI
Navarixin0
Placebo0
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28 Secondary · Day 28

Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.

GroupValue95% CI
Navarixin209.85± 51.50
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28 Secondary · Day 28

Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.

GroupValue95% CI
Navarixin420.37± 67.57
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28 Secondary · Day 28

Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.

GroupValue95% CI
Navarixin13.02± 6.63
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28 Secondary · Day 28

Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.

GroupValue95% CI
Navarixin0.500.50 – 1.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 43. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Navarixin
Serious: 0/21 (0%)
Deaths:
Placebo
Serious: 1/10 (10%)
Deaths:

Serious adverse events (1 terms)

ReactionSystemNavarixinPlacebo
Venous Thrombosis LimbVascular disorders
Other adverse events (8 terms — click to expand)

ReactionSystemNavarixinPlacebo
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
Pharyngolaryngeal PainRespiratory, thoracic and mediastinal disorders
Back PainMusculoskeletal and connective tissue disorders
HyperglycaemiaMetabolism and nutrition disorders
DiarrhoeaGastrointestinal disorders
FatigueGeneral disorders
DysmenorrhoeaReproductive system and breast disorders

Most-reported serious reactions: Venous Thrombosis Limb.

Data from ClinicalTrials.gov NCT00684593 adverse events section.

Sponsor's own description

This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.

Publications & conference data

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

  1. The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
    Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
  2. Multiple Roles for Chemokines in Neutrophil Biology.
    Capucetti A, Albano F, Bonecchi R. · · 2020 · cited 230× · PMID 32733442 · DOI 10.3389/fimmu.2020.01259
  3. Neutrophil diversity and function in health and disease.
    Zhang F, Xia Y, Su J, Quan F, et al · · 2024 · cited 109× · PMID 39638788 · DOI 10.1038/s41392-024-02049-y
  4. Role of chemokine systems in cancer and inflammatory diseases.
    Li H, Wu M, Zhao X. · · 2022 · cited 85× · PMID 35702353 · DOI 10.1002/mco2.147
  5. Wound healing and cancer stem cells: inflammation as a driver of treatment resistance in breast cancer.
    Arnold KM, Opdenaker LM, Flynn D, Sims-Mourtada J. · · 2015 · cited 84× · PMID 25674014 · DOI 10.4137/cgm.s11286
  6. CXCR2 chemokine receptor - a master regulator in cancer and physiology.
    Lazennec G, Rajarathnam K, Richmond A. · · 2024 · cited 53× · PMID 37872025 · DOI 10.1016/j.molmed.2023.09.003
  7. Therapeutic inhibition of CXCR1/2: where do we stand?
    Sitaru S, Budke A, Bertini R, Sperandio M. · · 2023 · cited 40× · PMID 37249756 · DOI 10.1007/s11739-023-03309-5
  8. Significance of the IL-8 pathway for immunotherapy.
    Gonzalez-Aparicio M, Alfaro C. · · 2020 · cited 37× · PMID 31860375 · DOI 10.1080/21645515.2019.1696075

Verify or expand the search:

Other trials of Navarixin 10 mg

Trials testing the same drug.

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00684593.

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