Efficacy and Safety of BMS-986165 versus Placebo and Active Comparator in Subjects with Psoriasis
- Conditions
- Moderate-to-Severe Plaque PsoriasisMedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-001926-25-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- 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
2)Infectious/Immune-related Exclusions
a)History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day1
b)History of serious bacterial, fungal, or viral infection requiring hospitalization and IV antimicrobial treatment within 60 days prior to Day1
c)Any untreated bacterial infection within 60 days prior to Day1
d)Any ongoing evidence of chronic, bacterial infection
e)Any history of proven infection of a joint prosthesis
f)Received live vaccines within 60 days prior to Day 1, 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 Day1
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)Any 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 Day1, or any planned surgery for the first 52 weeks of the study
b)Has donated blood >500mL within 4 weeks prior to Day1, or plans to donate blood during the course of the study
c)Illicit drug or alcohol abuse, as determined by the investigator, within 6 months prior to Day1
d)Any major illness/condition or evidence of an unstable clinical condition that will substantially increase the risk of participation
e)Unstable cardiovascular disease
f)Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) >160mm Hg or diastolic BP >100mm Hg
g)Class III or IV congestive heart failure
h) Has cancer or history of cancer or lymphoproliferative disease within the previous 5 years
i)Any significant/uncontrolled neuropsychiatric illness judged as clinically significant by the investigator during Screening or at Day1
OR Any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts at Screening or at Day 1, or is clinically deemed to have a suicide risk
j)Prior exposure to investigational product (ie, BMS-986165 or apremilast)
k)If the subject has received biologics previously, exclusion criteria for washout will apply
l)Has received systemic nonbiologic psoriasis medications and/or any systemic immunosuppressants within 4 weeks prior to Day1
m)Has used leflunomide within 6 months prior to Day1
n)Has used opioid analgesics within 4 weeks prior to Day1
o)Ha
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Assess whether BMS-986165 is superior to placebo at Week 16 in the treatment of subjects with moderate-to-severe plaque psoriasis;<br> Secondary Objective: 2. Assess whether BMS-986165 is superior to apremilast at Week 16<br> 3. Assess whether BMS-986165 is superior to apremilast at Week 52<br> 4. Assess whether BMS-986165 is superior to placebo over the first 16 weeks of treatment<br> 5. Assess whether BMS-986165 is superior to apremilast over 52 weeks of treatment<br> 6. Evaluate improvement in patient-reported outcomes for BMS-986165 compared with placebo through Week 16<br> 7. Evaluate improvement in patient-reported outcomes for BMS-986165 compared with apremilast through Week 24<br> 8. Evaluate maintenance of efficacy of BMS-986165 through Week 52<br> ;Primary end point(s): 1. sPGA 0/1 and PASI 75;Timepoint(s) of evaluation of this end point: at Week 16
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 2. - 5. sPGA 0/1, PASI 75, PASI 90, sPGA 0, PASI 100<br> 6. - 7.<br> • Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD)<br> symptom score, sign score, and total score<br> • Change from baseline in Dermatology Life Quality Index (DLQI) score<br> 8.<br> • Median time to first loss of PASI 75 among subjects that are PASI 75<br> responders at Week 24<br> • PASI 75 responders at Week 52 among subjects that are PASI 75 responders at Week 24<br> • sPGA 0/1 responders at Week 52 among subjects that are sPGA 0/1 responders at Week 24<br> ;<br> Timepoint(s) of evaluation of this end point: sPGA 0/1 and PASI 75 at Week 16<br> sPGA 0 at Week 16<br> PASI 90 at Week and at Week 52<br> PASI 100 at Week 16<br>