Phase IIa, Randomized, Double-Blind, Placebocontrolled, Multicenter Study to Assess the Safety, Tolerability, and Preliminary Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa
Sponsored by AstraZeneca, the purpose of this study is to
gain initial evidence for the safety, tolerability and efficacy of
MEDI8968 for the treatment of subjects with moderate to severe
hidradenitis suppurativa. The primary outcome measures
include a proportion of subjects achieving a clinically relevant
response in Physician Global Assessment (PGA), with score 0,
1, or 2 from baseline to 12 weeks, and a proportion of subjects
achieving a clinically significant response measured by the proportion
of subjects who achieve 0, 1, or 2 PGA by the end of
week 12. Other outcomes include subject's global Impression of
change reported on PGIC scale (1-7 point scale ranging from 1
"very much improved" to 7 "very much worse") over 12 weeks,
and the proportion of subjects achieving a clinically significant
response measured by the proportion of subjects who are "minimally
improved", "much improved", or "very much improved"
on the Patient's Global Impression of Change (PGIC).
Patients must have a diagnosis of HS for at least 1 year and
at least 5 active inflammatory lesions in at least 2 locations.
High Risk Cutaneous Squamous Cell Carcinoma Treated With Mohs Surgery Randomized to Elective Management of the Draining Lymph Nodes vs Periodic Clinical Nodal Observation
Sponsored by City of Hope Medical Center, this trial will
comprehensively evaluate the human papillomavirus (HPV)
vaccine in cancer survivors between 9 and 26 years of age
by (1) determining the prevalence of HPV vaccine initiation
among young cancer survivors, and (2) determining the immune
response to and safety/tolerability of the quadrivalent
HPV vaccine in young cancer survivors.
The primary objectives are will use a cross-sectional survey
approach, estimate the prevalence of HPV vaccine non-initiation:
Examine sociodemographic, behavioral, and medical
determinants of HPV vaccine non-initiation. Using a singlearm,
phase II, open-label, prospective longitudinal trial design,
to evaluate the 3-dose quadrivalent (q) HPV vaccine series and
measure the following endpoints: a) Determine immunogenicity
following the third and final vaccine dose; b) Identify
clinical/host factors influencing immunogenicity; c) Determine
the safety/tolerability of the qHPV vaccine in cancer survivors.
Evaluate the persistence of antibody response at 2 years post
vaccine initiation and identify clinical/host factors influencing
response persistence.
Patients for the survey must be a cancer survivor, and between
12 and 60 months after completion of cancer therapy (chemotherapy,
radiation, hematopoietic cell transplant [HCT]).
Phase II, Randomized, Double Blinded, Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
Sponsored by Novartis, This study is designed to evaluate the proportion
of patients achieving reversal of chronic plaque psoriasis
at week 4 and 12 following multiple doses of secukinumab administered
subcutaneously (sc) compared to placebo. Starting from
week 13, all patients will receive multiple doses of secukinumab
up to week 52 to study long term effects of secukinumab. Clinical
endpoints including biomarker assessments, PASI, IGA, and
DLQI will be compared to better understand, why secukinumab
may be effective in psoriasis patients. The primary outcome
measure is for patients to achieve skin histology response after
secukinumab treatment after 12 weeks of treatment.
Patients being tested have chronic plaque-type psoriasis diagnosed
for at least 6 months, moderate to severe psoriasis
as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body
surface area) affected by plaque-type psoriasis of ≥10%, and
chronic plaque-type psoriasis considered inadequately controlled
by: topical treatment and/or; phototherapy and/or
previous systemic therapy.
