A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy

NCT03930186 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: CC-10004-PSOR-023U1111-1230-746820200062
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 56

Brief Summary

The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16

  The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.

  Week 16

Secondary Outcomes (13)

• Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32

  Week 32

• Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32

  Weeks 16 and 32

• Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32

  Baseline and weeks 16 and 32

• Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32

  Baseline and weeks 2, 16, and 32

• Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32

  Baseline and weeks 2, 16, and 32

Study Arms (1)

Apremilast

EXPERIMENTAL

After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician.

Drug: Apremilast; Drug: Topical Therapy

Interventions

Apremilast DRUG

Tablets for oral administration

Also known as: CC-10004, Otezla®

Apremilast

Topical Therapy DRUG

Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.

Apremilast

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
• Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
• Subject is able to adhere to the study visit schedule and other protocol requirements.
• Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
• Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
• Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.
• Subject has inadequate response to current topical therapy as per Investigator's discretion.
• Subject is naïve to all biologic therapies for psoriasis vulgaris.
• Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
• (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
• Subjects that are females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product 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; 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.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, pustular, inverse, erythrodermic, or guttate), other than plaque psoriasis.
• Subject has psoriatic arthritis that requires systemic therapy.
• Subject has history of drug-induced psoriasis.
• Subject has had prior treatment with biologic therapies for psoriasis.
• Subject has used phototherapy or conventional systemic therapy for psoriasis within 8 weeks prior to baseline and during the study (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine).
• Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from Screening to Baseline.
• Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8 weeks prior to Baseline and during the study.
• Subject is currently enrolled in any other clinical trial involving an investigational product.
• Subject has other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
• Subject has malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas.
• Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
• Subject is pregnant or breastfeeding (lactating) women.
• Subject has bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
• Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive at screening.

Sponsors & Collaborators

• Amgen: lead

Study Sites (56)

Research Site

Erlangen, 91054, Germany

Location

Research Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Research Site

Fukuoka-shi, Fukuoka, Fukuoka, 813-0044, Japan

Location

Research Site

Fukuoka-shi, Fukuoka, Fukuoka, 819-0167, Japan

Location

Research Site

Obihiro-shi, Hokkaido, 080-0013, Japan

Location

Research Site

Sapporo, Hokkaido, 060-0063, Japan

Location

Research Site

Sapporo, Hokkaido, 062-0042, Japan

Location

Research Site

Sakai-shi, Osaka, 593-8324, Japan

Location

Research Site

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Research Site

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Motomachi Dermatology Clinic

Asahikawa-shi, Hokkaido, 070-0810, Japan

Location

Research Site

Asahikawa-shi, Hokkaido, 070-0810, Japan

Location

Nippon Medical School Hospital

Bunkyō City, 113-8602, Japan

Location

The University of Tokyo Hospital

Bunkyō City, 113-8655, Japan

Location

Chitose Dermatology and Plastic, Reconstructive Surgery Clinic

Chitose, 066-0021, Japan

Location

Research Site

Chitose, 066-0021, Japan

Location

Kiryu Dermatology Clinic

Fukuoka-shi, Fukuoka, 813-0044, Japan

Location

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, 814-0180, Japan

Location

Tomoko Matsuda Dermatology Clinic

Fukuoka-shi, Fukuoka, 819-0167, Japan

Location

Hino Dermatology Clinic

Fukutsu, 811-3217, Japan

Location

Research Site

Fukutsu, 811-3217, Japan

Location

Research Site

Kagoshima, 890-0055, Japan

Location

Saruwatari Dermatology Clinic

Kagoshima, 890-0055, Japan

Location

Noguchi Dermatorogy Clinic

Kamimashiki-gun, 861-3101, Japan

Location

Research Site

Kamimashiki-gun, 861-3101, Japan

Location

Japan Community Health-care Organization Kyushu Hospital

Kitakyushu, 806-8501, Japan

Location

Research Site

Kitakyushu, 806-8501, Japan

Location

Maruyama Dermatology Clinic

Koto-ku, Tokyo, 136-0074, Japan

Location

Research Site

Koto-ku, Tokyo, 136-0074, Japan

Location

Mita Dermatology Clinic

Minatoku, 108-0014, Japan

Location

Research Site

Minatoku, 108-0014, Japan

Location

Iwate Medical University Uchimaru Medical Center

Morioka, 020-8505, Japan

Location

Research Site

Morioka, 020-8505, Japan

Location

Research Site

Neyagawa, 572-0838, Japan

Location

Yoshioka Dermatology Clinic

Neyagawa, 572-0838, Japan

Location

Takagi Dermatological Clinic

Obihiro, 080-0013, Japan

Location

Nippon Life Hospital

Osaka, 550-0006, Japan

Location

Research Site

Osaka, 550-0006, Japan

Location

Hino Clinic

Sakai, 599-8272, Japan

Location

Research Site

Sakai, 599-8272, Japan

Location

Kume Clinic

Sakai-shi, Osaka, 593-8324, Japan

Location

Kitagou Dermatology Clinic

Sapporo, 003-0833, Japan

Location

Research Site

Sapporo, 003-0833, Japan

Location

Kobayashi Skin Clinic

Sapporo, 060-0807, Japan

Location

Research Site

Sapporo, 060-0807, Japan

Location

Hosui Medical Clinic

Sapporo, 064-0807, Japan

Location

Research Site

Sapporo, 064-0807, Japan

Location

Sapporo Skin Clinic

Sapporo-shi, Hokkaido, 060-0063, Japan

Location

Fukuzumi Dermatology Clinic

Sapporo-shi, Hokkaido, 062-0042, Japan

Location

Jichi Medical University Hospital

Shimotsuke, 329-0498, Japan

Location

Research Site

Shimotsuke, 329-0498, Japan

Location

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Research Site

Shinjyuku-ku, 160-0023, Japan

Location

Tokyo Medical University Hospital

Shinjyuku-ku, 160-0023, Japan

Location

Fujita Health University Hospital

Toyoake, 470-1192, Japan

Location

Research Site

Toyoake, 470-1192, Japan

Location

Related Publications (2)

• Abe M, Okubo Y, Takahashi H, Endo K, Chaudhari S, Deignan C, Amouzadeh H, Hino R. Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT. Dermatol Ther (Heidelb). 2024 Jun;14(6):1587-1597. doi: 10.1007/s13555-024-01179-z. Epub 2024 May 27.

  PMID: 38801606 DERIVED

• Okubo Y, Takahashi H, Hino R, Endo K, Kikuchi S, Ozeki Y, Nakamura T, Paris M, Abe M. Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study. Dermatol Ther (Heidelb). 2022 Jun;12(6):1469-1480. doi: 10.1007/s13555-022-00747-5. Epub 2022 Jun 11.

  PMID: 35689737 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

apremilast; Therapeutics

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: June 17, 2019
• Primary Completion: May 8, 2020
• Study Completion: September 25, 2020
• Last Updated: January 20, 2022
• Results First Posted: January 20, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

DE (1); JP (55)