Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03123471
Other study ID # CC-10004-SPSO-001
Secondary ID U1111-1194-1248
Status Completed
Phase Phase 3
First received
Last updated
Start date May 16, 2017
Est. completion date January 9, 2019

Study information

Verified date April 2020
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Approximately 300 subjects with moderate to severe plaque psoriasis of the scalp will be randomized 2:1 to receive either apremilast 30 mg twice daily (BID) or placebo for the first 16 weeks.


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 receive treatment with one of the following:

- 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 who had received placebo during the placebo-controlled phase will be switched to apremilast 30 mg BID (or continue with) apremilast. At Week 16, all subjects will maintain this dosing through Week 32.

- Observational Follow-up Phase

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


Recruitment information / eligibility

Status Completed
Enrollment 303
Est. completion date January 9, 2019
Est. primary completion date August 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

- Males or females, = 18 years of age at the time of signing the informed consent document

- Be willing and able to adhere to the study visit schedule and other protocol requirements.

- Have a diagnosis of moderate to severe plaque psoriasis of the scalp at screening and baseline

- Must be a candidate for phototherapy and/or systemic therapy for either body or scalp psoriasis lesions.

- Have moderate to severe plaque psoriasis at screening and baseline

- Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratories, and urinalysis

- Must meet laboratory criteria

- Females of childbearing potential (FCBP)* must have a negative pregnancy test at screening and baseline. While on investigational product (IP) and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible - must use one of the approved contraceptive** options described below:

Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

*A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months).

** The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

- Other than psoriasis, history of any clinically significant uncontrolled disease.

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.

- Pregnant or breast feeding

- Hepatitis B surface antigen positive at screening

- Anti-hepatitis C antibody positive at screening

- Active tuberculosis (TB) or a history of incompletely treated TB

- Clinically significant abnormality on 12-lead electrocardiogram (ECG) at screening

- History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)

- Active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent form.

- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of signing the informed consent form.

- Malignancy or history of malignancy, except for treated (i.e., cured) basal cell or squamous cell in situ skin carcinomas or treated (i.e., cured) cervical intraepithelial neoplasia (CIN) or carcinoma in situ of the cervix with no evidence of recurrence within 5 years of signing the informed consent.

- Prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and randomization, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.

- Psoriasis flare/rebound within 4 weeks of signing the informed consent form or between the screening and baseline visits.

- Topical therapy within 2 weeks prior to randomization; Conventional systemic therapy for psoriasis within 4 weeks prior to randomization; Intralesional corticosteroids on the scalp within 2 weeks prior to randomization; Phototherapy treatment of body or scalp psoriasi lesions within 4 weeks prior to randomization; Biologic therapy between 12 weeks to 24 weeks prior to randomization

- Use of any investigational drug beginning 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)

- Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources

- Prior treatment with apremilast

- History of allergy or hypersensitivity to any components of the Investigational product.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Apremilast
Apremilast 30 mg tablets BID from weeks 0 to 32.
Other:
Placebo
Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.

Locations

Country Name City State
Canada Institute for Skin Advancement Calgary Alberta
Canada Kirk Barber Research Calgary Alberta
Canada Lynderm Research Markham Ontario
Canada North Bay Dermatology Center North Bay Ontario
Canada Skin Center for Dermatology Peterborough Ontario
Canada Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ Quebec
Canada Centre For Dermatology and Cosmetic Surgery Richmond Hill Ontario
Canada Chih-Ho Hong Medical, Inc. Surrey British Columbia
Canada Enverus Medical Research Surrey British Columbia
Canada The Toronto Dermatology Centre Toronto Ontario
Canada K. Papp Clinical Research Waterloo Ontario
Canada XLR8 Medical Research Windsor Ontario
Canada Wiseman Dermatology Research Inc. Winnipeg Manitoba
United States Austin Dermatology Associates Austin Texas
United States SUNY Downstate Medical Center Brooklyn New York
United States Florida Academic Centers Research and Education Coral Gables Florida
United States Modern Research Associates PLLC Dallas Texas
United States Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey
United States Wright State Physicians Fairborn Ohio
United States University of Connecticut Farmington Connecticut
United States Forest Hills Dermatology Group Forest Hills New York
United States Tien Q. Nguyen MD Inc Fountain Valley California
United States Dermatology and Advanced Aesthetics Lake Charles Louisiana
United States Dermatology Research Associates Los Angeles California
United States DS Research Louisville Kentucky
United States DS Research Louisville Kentucky
United States Dermatologic Surgery Specialists, P.C. Macon Georgia
United States International Dermatology Research Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Icahn School of Medicine at Mount Sinai Medical Center New York New York
United States Sadick Research Group New York New York
United States MedaPhase INC Newnan Georgia
United States Eastern Virginia Medical School Norfolk Virginia
United States Virginia Clinical Research Inc Norfolk Virginia
United States Renstar Medical Research Ocala Florida
United States Skin Specialists, PC Omaha Nebraska
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States The Indiana Clinical Trials Center, PC Plainfield Indiana
United States Lawrence Green, MD, LLC Rockville Maryland
United States Northwest Arkansas Clinical Trials Center, PLLC / Hull Dermatology Rogers Arkansas
United States Central Dermatology Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States San Luis Dermatology and Laser Clinic San Luis Obispo California
United States Center for Clinical Studies Webster Texas
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions. Baseline to Week 16
Secondary Percentage of Participants With = 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16 The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a = 4-point reduction (improvement) from baseline. Baseline to Week 16
Secondary Percentage of Participants With = 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16 The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch. Baseline to Week 16
Secondary Percentage of Participants With = 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. Baseline to Weeks 2, 4, 6, 8 and 12
Secondary Percentage of Participants With = 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where "0" represents no itch, and "10" represents the worst imaginable itch. Baseline to Weeks 2, 4, 8 and 12
Secondary Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16 DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. Baseline to Week 16
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort. Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.
Secondary Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort. Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively
Secondary Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort. Week 0 to 32;
See also
  Status Clinical Trial Phase
Completed NCT03236870 - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed NCT00078819 - Etanercept (Enbrel®) in Psoriasis - Pediatrics Phase 3
Completed NCT04841187 - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting NCT03927352 - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis Phase 3
Completed NCT03284879 - Post-Marketing Surveillance Study of OTEZLA
Recruiting NCT06027034 - Effectiveness of a Digital Health Application for Psoriasis N/A
Not yet recruiting NCT06050330 - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study N/A
Recruiting NCT05744466 - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed NCT04149587 - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed NCT01384630 - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis Phase 2
Completed NCT03998683 - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis Phase 3
Terminated NCT03556202 - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06077331 - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT04316585 - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants Phase 1
Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Completed NCT05003531 - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Phase 2