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Apremilast as a Direct Treatment for Mild-to-moderate Plaque Psoriasis Versus Placebo: an Analysis of Clinical Safety and Efficacy (ADVANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03721172
Recruitment Status : Active, not recruiting
First Posted : October 26, 2018
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Psoriasis Drug: Apremilast Other: Placebo Phase 3

Detailed Description:

The study will consist of four phases:

  • Screening Phase - up to 35 days
  • Double-blind Placebo-controlled Phase - Weeks 0 to 16

    - Subjects will be randomly assigned to either apremilast 30 mg tablets orally BID or placebo tablets (identical in appearance to apremilast 30 mg tablets) orally BID.

  • Apremilast Extension Phase - Weeks 16 to 32

    - All subjects will be switched to (or continue with) apremilast 30 mg BID. All subjects will maintain this dosing through Week 32.

  • Observational Follow-up Phase - 4 weeks - Four-week Post-Treatment Observational Follow-up Phase for all subjects who complete the study or discontinue the study early.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 595 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, STUDY OF THE EFFICACY AND SAFETY Of APREMILAST (CC-10004), COMPARED TO PLACEBO, IN SUBJECTS WTIH MILD TO MODERATE PLAQUE PSORIASIS
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : March 6, 2020
Estimated Study Completion Date : July 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Apremilast 30 mg or Placebo
Oral Apremilast 30 mg or placebo twice daily (BID) from Week 0 to Week 16
Drug: Apremilast
Apremilast, oral, twice daily

Other: Placebo
Placebo, oral, twice daily

Experimental: Apremilast 30 mg, extension
Apremilast 30 mg twice daily (BID) from Week 16 to Week 32
Drug: Apremilast
Apremilast, oral, twice daily




Primary Outcome Measures :
  1. 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. [ Time Frame: Up to week 16 ]
    Static Physician Global Assessment (sPGA) 0/1


Secondary Outcome Measures :
  1. Proportion of subjects who improved ≥ 75% in BSA from baseline at Week 16. [ Time Frame: Up to week 16 ]
    Body Surface Area (BSA)

  2. Body Surface Area (BSA)changes [ Time Frame: Up to week 16 ]
    Change from baseline in affected BSA at Week 16.

  3. Psoriasis Area and Severity Index (PASI) [ Time Frame: Up to week 16 ]
    Change from baseline in total PASI score at Week 16

  4. Proportion of subjects with BSA ≤ 3% [ Time Frame: Up to week 16 ]
    Proportion of subjects who achieved BSA ≤ 3% for subjects with baseline BSA > 3% at Week 16.

  5. 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. [ Time Frame: Up to week 16 ]
    Whole body itch numeric rating scale (NRS)

  6. 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. [ Time Frame: Up to week 16 ]
    Scalp Physician Global Assessment (ScPGA)

  7. Dermatology Life Quality Index (DLQI) [ Time Frame: Up to week 16 ]
    Change from baseline in DLQI total score at Week 16

  8. Adverse Events (AEs) [ Time Frame: From signed the informed consent until at least 28 days after completion of study treatment ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721172


Locations
Show Show 64 study locations
Sponsors and Collaborators
Amgen

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03721172    
Other Study ID Numbers: CC-10004-PSOR-022
U1111-1218-8372 ( Registry Identifier: WHO )
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Phase 3
Double-Blind
Efficacy
Safety
Apremilast
Otezla
CC-10004
Plaque Psoriasis
Mild
Moderate
Scalp
Nail
Itch
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents