Clinical trial NCT03930186: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32
timeFrame: Week 32
measure: Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32
timeFrame: Weeks 16 and 32
measure: Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32
timeFrame: Baseline and weeks 16 and 32
measure: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32
timeFrame: Baseline and weeks 2, 16, and 32
measure: Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32
timeFrame: Baseline and weeks 2, 16, and 32
measure: Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline
timeFrame: Weeks 16 and 32
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32
timeFrame: Baseline and weeks 16 and 32
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32
timeFrame: Baseline and weeks 16 and 32
measure: Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)
timeFrame: Weeks 16 and 32
measure: Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)
timeFrame: Weeks 16 and 32
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores
timeFrame: Baseline and weeks 16 and 32
measure: Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32
timeFrame: Weeks 16 and 32
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Research Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Obihiro-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sakai-shi
country: Japan
facility: Research Site
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Motomachi Dermatology Clinic
city: Asahikawa-shi, Hokkaido
country: Japan
facility: Research Site
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Chitose
country: Japan
facility: Chitose Dermatology and Plastic, Reconstructive Surgery Clinic
city: Chitose
country: Japan
facility: Research Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Kiryu Dermatology Clinic
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Tomoko Matsuda Dermatology Clinic
city: Fukutsu
country: Japan
facility: Hino Dermatology Clinic
city: Fukutsu
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Saruwatari Dermatology Clinic
city: Kamimashiki-gun
country: Japan
facility: Noguchi Dermatorogy Clinic
city: Kamimashiki-gun
country: Japan
facility: Research Site
city: Kitakyushu-city
country: Japan
facility: Japan Community Health-care Organization Kyushu Hospital
city: Kitakyushu-city
country: Japan
facility: Research Site
city: Koto-ku, Tokyo
country: Japan
facility: Maruyama Dermatology Clinic
city: Koto-ku, Tokyo
country: Japan
facility: Research Site
city: Minato-ku
country: Japan
facility: Mita Dermatology Clinic
city: Minato-ku
country: Japan
facility: Research Site
city: Morioka
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
city: Morioka
country: Japan
facility: Research Site
city: Neyagawa
country: Japan
facility: Research Site
city: Neyagawa
country: Japan
facility: Yoshioka Dermatology Clinic
city: Obihiro
country: Japan
facility: Takagi Dermatological Clinic
city: Osaka
country: Japan
facility: Nippon Life Hospital
city: Osaka
country: Japan
facility: Research Site
city: Sakai-shi, Osaka
country: Japan
facility: Kume Clinic
city: Sakai
country: Japan
facility: Hino Clinic
city: Sakai
country: Japan
facility: Research Site
city: Sapporo-shi, Hokkaido
country: Japan
facility: Sapporo Skin Clinic
city: Sapporo-shi, Hokkaido
country: Japan
facility: Fukuzumi Dermatology Clinic
city: Sapporo
country: Japan
facility: Kitagou Dermatology Clinic
city: Sapporo
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Kobayashi Skin Clinic
city: Sapporo
country: Japan
facility: Research Site
city: Sapporo
country: Japan
facility: Hosui Medical Clinic
city: Sapporo
country: Japan
facility: Research Site
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Shimotsuke
country: Japan
facility: Research Site
city: Shinagawa-ku, Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Shinjyuku-ku
country: Japan
facility: Research Site
city: Shinjyuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Toyoake
country: Japan
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.