Efficacy and Safety of BMS-986165 versus Placebo and Active Comparator in Subjects with Psoriasis
- Conditions
- Moderate-to-Severe Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001926-25-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1) Signed Written Informed Consent
a) Subjects must be willing to participate in the study and sign the informed consent form (ICF)
2) Type of Subject and Target Disease Characteristics
a) Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator
b) Deemed by the investigator to be a candidate for phototherapy or systemic therapy
c) =10% of BSA involvement at Screening Visit and Day 1
d) Psoriasis Area and Severity Index (PASI) score =12 and static Physician’s Global Assessment (sPGA) =3 at Screening Visit and Day 1
3) Age and Reproductive Status
a) Men and women aged =18 years at the time of Screening Visit
b) Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening Visit, and a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study drug
c) Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period
d) Women of childbearing potential must agree to use correctly a highly effective method(s) of contraception for the duration of treatment (52 weeks) with study drug(s) BMS-986165
plus 5 half-lives of study drug (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion (total of 33 days after last dose of study drug).
WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements, but must still undergo pregnancy testing as described in this protocol
e) Male subjects who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (APPENDIX 4) for the duration of treatment with study treatment(s) plus 5 half-lives of the study treatment (3 days) for a total of 3 days post-treatment completion. In addition, male subjects must be willing to refrain from sperm donation during this time
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1)Target Disease Exceptions
a)Has nonplaque psoriasis at Screening or Day1(D1)
2)Infectious/Immune-related Exclusions
a)History or evidence of outpatient active infection and/or febrile illness
within 7 days prior to D1
b)History of serious bacterial, fungal, or viral infection requiring hospitalization and IV antimicrobial treatment within 60 days prior to
D1
c)Untreated bacterial infection within 60 days prior to D1
d)Ongoing evidence of chronic, bacterial infection
e)History of proven infection of a joint prosthesis
f)Received live vaccines within 60 days prior to D1, or plans to receive a live vaccine during the study, or within 60 days after completing study treatment
g)Presence of herpes zoster lesions at Screening or D1
h)History of serious herpes zoster or serious herpes simplex infection
i+j)Evidence of, or test positive for HBV and HCV at Screening
k)Positive for HIV-1 and -2 Ab at Screening
l)History of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status
3)Any of the following TB criteria
a)History of active TB prior to Screening
b)Signs or symptoms of active TB during screening
c)Any imaging of the chest showing evidence of current active or history
of active pulmonary TB
d)Latent TB infection defined as positive IFN gamma release assay at Screening, in the absence of clinical manifestations
4)Medical History and Concurrent Diseases
a)Any major surgery within 8 weeks prior to D1, or any planned surgery for the first 52 weeks of the study
b)Donated blood >500mL within 4 weeks prior to D1, or plans to donate blood during the course of the study
c)Drug or alcohol abuse, as determined by the investigator, within 6 months prior to D1
d)Medical marijuana
e)Major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk of participation
f)Unstable cardiovascular disease
g)Uncontrolled arterial hypertension characterized by a systolic blood
pressure (BP) >160mmHg or diastolic BP >100mmHg
h)Class III or IV congestive heart failure
i)Has cancer or history of cancer or lymphoproliferative disease within
the previous 5 years
j)Significant/uncontrolled neuropsychiatric illness judged as clinically
significant by the investigator during Screening or at D1
OR Any lifetime history of suicidal ideation, suicidal behavior, or suicidal
attempts at Screening or at D1, or is clinically deemed to have suicide risk
k)Prior exposure to investigational product (ie, BMS-986165 or apremilast)
l)If the subject has received biologics previously, exclusion criteria for
washout will apply
m)Received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressants within 4 weeks prior to D1
n)Used leflunomide within 6 months prior to D1
o)Used opioid analgesics within 4 weeks prior to D1
p)Received lithium, antimalarials, or intramuscular gold within 4 weeks
of the first administration of any study medication
q)Used any strong CYP450 inducers within 4 weeks prior to D1
r)Received phototherapy within 4 weeks prior to D1
s)Used topical medications/treatments that could affect psoriasis
evaluation within 2 weeks prior to D1
t)Use of shampoos that contain corticosteroids, coal tar, >3% salicylic
acid, or vitamin D3 analogues within 2 weeks prior to D1
u)Received an experimental antibody or experimental biologic therapy
within the previous 6 months, OR received any other experimental
therapy or new investigational agent w
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method