Back to Search Results
Study Complete
Sponsor ID
CC-10004-PSOR-022

Apremilast as a direct treatment for mild-to-moderate plaque psoriasis versus placebo: an analysis of clinical safety and efficacyADVANCE

Sponsor ID
CC-10004-PSOR-022
Clinicaltrials.gov ID
NCT03721172
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with mild to moderate plaque psoriasis.

Approximately 574 subjects with mild to moderate plaque psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
595
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of subjects with an sPGA score of clear (0) or almost clear (1) and with at least a 2- point reduction from baseline at Week 16.

Timeframe: Up to week 16

Secondary Outcome Measures

Proportion of subjects who improved ≥ 75% in BSA from baseline at Week 16.

Timeframe: Up to week 16

Body Surface Area (BSA)changes

Timeframe: Up to week 16

Psoriasis Area and Severity Index (PASI)

Timeframe: Up to week 16

Proportion of subjects with BSA ≤ 3%

Timeframe: Up to week 16

Proportion of subjects with ≥4-point reduction (improvement) from baseline in the whole-body itch NRS score at Week 16 among subjects with baseline whole body itch NRS ≥ 4.

Timeframe: Up to week 16

Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16 among subjects with baseline ScPGA score ≥ 2.

Timeframe: Up to week 16

Dermatology Life Quality Index (DLQI)

Timeframe: Up to week 16

Adverse Events (AEs)

Timeframe: From signed the informed consent until at least 28 days after completion of study treatment

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)
Plain Language Summary of Results
Available Language(s): English, Spanish (United States), French (Canadian)
Download Document(s)

Locations

Location
Status
Contact Us
Location
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
Status
Recruiting
Location
Stratica Medical
Edmonton, Alberta, Canada, T5K 1X3
Status
Recruiting
Location
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States, 08520
Status
Recruiting
Location
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Status
Recruiting
Location
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Status
Recruiting
Location
Lynderm Research
Markham, Ontario, Canada, L3P 1X2
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Mar 2019 - Mar 2020
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject must be male or female, ≥18 years of age at the time of signing the informed consent form (ICF). 2. Subject must have a diagnosis of chronic plaque psoriasis for at least 6 months prior to signing the ICF. 3. Subject must have a diagnosis of mild to moderate plaque psoriasis at both Screening and Baseline. 4. Subject must be inadequately controlled with or intolerant of at least one topical therapy at both Screening and Baseline. 5. Subject must be in good health (except for psoriasis) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. 6. Subject must meet laboratory criteria. 7. Subject has not had prior exposure to biologics for the treatment of psoriatic arthritis or psoriasis, or any other condition that could impact the assessment of psoriasis.
    Exclusion Criteria:
    The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subjects has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. 2. Subject has hepatitis B surface antigen positive at Screening. 3. Subject has active tuberculosis (TB) or a history of incompletely treated TB. 4. Subject has history of positive human immunodeficiency virus (HIV), or has congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease). 5. Subject has hepatitis B surface antigen or anti-hepatitis C antibody positive at Screening. 6. Subject has prior history of suicide attempt at any time in the subject’s life time or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent. 7. Subject has current or planned concurrent use of therapies that may have a possible effect on psoriasis during the course of the treatment phase of the trial. 8. Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). 9. Subject had prior treatment with apremilast.