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

17 janvier 2019 mis à jour par: Merck Sharp & Dohme LLC

A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

31

Phase

  • Phase 2

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).
  • Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion. Participants must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, participants must have a PASI >8 following washout of their current psoriasis therapy.
  • Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. Severity score for desquamation must be at least 2.
  • Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm.
  • Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
  • Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participants must have a neutrophil count of at least 2 x 10^9/L to be included.
  • Free of any clinically significant disease (other than psoriasis).
  • Willing to give written informed consent and able to adhere to dose and visit schedules.
  • For female participants: Negative serum pregnancy test (beta-hCG) and urine pregnancy test. Agree to use medically accepted methods of contraception during and for an appropriate pre-study period while receiving protocol specified medication, and for 1 month after stopping medication. Female participants of non-childbearing potential must be surgically sterilized or be postmenopausal.
  • Male subject must agree to use an adequate form of contraception for the duration of the study.
  • At Screening, ECG conduction intervals must be within gender specific normal range (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range, the values must be considered clinically insignificant by the investigator and sponsor.

Exclusion Criteria:

  • Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
  • Participants who, in the opinion of the investigator, will not be able to participate optimally in the study.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
  • Immunocompromised participants.
  • Positive screen for drugs with a high potential for abuse or have a history of drug or alcohol abuse in the past 2 years.
  • History of mental instability or who have been treated for mood disorders.
  • Donated blood in the past 60 days.
  • Previous treatment with study medication.
  • Currently participating in another clinical study or have participated in a clinical study within 30 days.
  • Part of the study staff personnel or family members of the study staff personnel.
  • Demonstrated clinically significant (requiring intervention) allergic reactions or who are known to be allergic to components of local anesthetics.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Navarixin
Navarixin 30 mg administered orally once daily for 28 days.
Navarixin capsules orally, once daily for 28 days.
Comparateur placebo: Placebo
Matching placebo to Navarixin administered orally once daily for 28 days.
Matching placebo capsules to Navarixin orally, once daily for 28 days.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
Délai: 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).
Baseline and Day 29

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Délai: 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.
Day 29
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Délai: 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.
Day 28
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Délai: 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.
Day 28
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
Délai: 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.
Day 28
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
Délai: 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.
Day 28

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2007

Achèvement primaire (Réel)

1 octobre 2007

Achèvement de l'étude (Réel)

1 octobre 2007

Dates d'inscription aux études

Première soumission

22 mai 2008

Première soumission répondant aux critères de contrôle qualité

22 mai 2008

Première publication (Estimation)

26 mai 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 février 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 janvier 2019

Dernière vérification

1 janvier 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • P04481 (Autre identifiant: Merck Protocol Number)
  • 2006-006601-83 (Numéro EudraCT)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Données/documents d'étude

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Navarixin 10 mg

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