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

NCT ID: NCT03930186

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2020-09-25

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.

Detailed Description

Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apremilast

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.

Group Type: EXPERIMENTAL

Apremilast

Intervention Type: DRUG

Tablets for oral administration

Topical Therapy

Intervention Type: 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.

Interventions

Apremilast

Tablets for oral administration

Intervention Type: DRUG

Topical Therapy

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.

Intervention Type: DRUG

Other Intervention Names

CC-10004; Otezla®

Eligibility Criteria

Inclusion Criteria

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

1. Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.

2. Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.

3. Subject is able to adhere to the study visit schedule and other protocol requirements.

4. Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.

5. Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.

6. Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.

7. Subject has inadequate response to current topical therapy as per Investigator's discretion.

8. Subject is naïve to all biologic therapies for psoriasis vulgaris.

9. 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).

10. 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.

Exclusion Criteria

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

1. 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.

2. Subject has psoriatic arthritis that requires systemic therapy.

3. Subject has history of drug-induced psoriasis.

4. Subject has had prior treatment with biologic therapies for psoriasis.

5. 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).

6. Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from Screening to Baseline.

7. Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8 weeks prior to Baseline and during the study.

8. Subject is currently enrolled in any other clinical trial involving an investigational product.

9. 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.

10. 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.

11. Subject has received a live vaccine within 3 months of baseline or plans to do so during study.

12. Subject is pregnant or breastfeeding (lactating) women.

13. 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.

14. Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive at screening.

15. Subject is positive for antibodies to hepatitis C at screening.

16. Subject 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.

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

18. Subject has active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.

19. Subject has prior treatment with apremilast or participation in a clinical study involving apremilast.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Erlangen, , Germany

Research Site

Fukuoka, Fukuoka, Japan

Research Site

Fukuoka-shi, Fukuoka, Fukuoka, Japan

Research Site

Fukuoka-shi, Fukuoka, Fukuoka, Japan

Research Site

Obihiro-shi, Hokkaido, Japan

Research Site

Sapporo, Hokkaido, Japan

Research Site

Sapporo, Hokkaido, Japan

Research Site

Sakai-shi, Osaka, Japan

Research Site

Bunkyo-ku, Tokyo, Japan

Research Site

Bunkyo-ku, Tokyo, Japan

Motomachi Dermatology Clinic

Asahikawa-shi, Hokkaido, , Japan

Research Site

Asahikawa-shi, Hokkaido, , Japan

Nippon Medical School Hospital

Bunkyō City, , Japan

The University of Tokyo Hospital

Bunkyō City, , Japan

Chitose Dermatology and Plastic, Reconstructive Surgery Clinic

Chitose, , Japan

Research Site

Chitose, , Japan

Kiryu Dermatology Clinic

Fukuoka-shi, Fukuoka, , Japan

Fukuoka University Hospital

Fukuoka-shi, Fukuoka, , Japan

Tomoko Matsuda Dermatology Clinic

Fukuoka-shi, Fukuoka, , Japan

Hino Dermatology Clinic

Fukutsu, , Japan

Research Site

Fukutsu, , Japan

Research Site

Kagoshima, , Japan

Saruwatari Dermatology Clinic

Kagoshima, , Japan

Noguchi Dermatorogy Clinic

Kamimashiki-gun, , Japan

Research Site

Kamimashiki-gun, , Japan

Japan Community Health-care Organization Kyushu Hospital

Kitakyushu, , Japan

Research Site

Kitakyushu, , Japan

Maruyama Dermatology Clinic

Koto-ku, Tokyo, , Japan

Research Site

Koto-ku, Tokyo, , Japan

Mita Dermatology Clinic

Minatoku, , Japan

Research Site

Minatoku, , Japan

Iwate Medical University Uchimaru Medical Center

Morioka, , Japan

Research Site

Morioka, , Japan

Research Site

Neyagawa, , Japan

Yoshioka Dermatology Clinic

Neyagawa, , Japan

Takagi Dermatological Clinic

Obihiro, , Japan

Nippon Life Hospital

Osaka, , Japan

Research Site

Osaka, , Japan

Hino Clinic

Sakai, , Japan

Research Site

Sakai, , Japan

Kume Clinic

Sakai-shi, Osaka, , Japan

Kitagou Dermatology Clinic

Sapporo, , Japan

Research Site

Sapporo, , Japan

Kobayashi Skin Clinic

Sapporo, , Japan

Research Site

Sapporo, , Japan

Hosui Medical Clinic

Sapporo, , Japan

Research Site

Sapporo, , Japan

Sapporo Skin Clinic

Sapporo-shi, Hokkaido, , Japan

Fukuzumi Dermatology Clinic

Sapporo-shi, Hokkaido, , Japan

Jichi Medical University Hospital

Shimotsuke, , Japan

Research Site

Shimotsuke, , Japan

NTT Medical Center Tokyo

Shinagawa-ku, Tokyo, , Japan

Research Site

Shinjyuku-ku, , Japan

Tokyo Medical University Hospital

Shinjyuku-ku, , Japan

Fujita Health University Hospital

Toyoake, , Japan

Research Site

Toyoake, , Japan

Countries

Germany; Japan

References

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.

Reference Type: DERIVED

PMID: 38801606 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35689737 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

U1111-1230-7468

Identifier Type: REGISTRY

Identifier Source: secondary_id

20200062

Identifier Type: OTHER

Identifier Source: secondary_id

CC-10004-PSOR-023

Identifier Type: -

Identifier Source: org_study_id