A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
NCT ID: NCT04057937
Last Updated: 2024-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2019-10-16
2021-06-07
Brief Summary
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The placebo-controlled period will be 16 weeks and patients will receive apremilast or placebo. After the 16-week placebo-controlled period, all subjects will receive apremilast for 16 weeks. All subjects will have their final study visit 4 weeks after stopping apremilast treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo then Apremilast 30mg BID
Participants received matched placebo as oral tablets twice daily (BID) for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
Apremilast
Apremilast
Placebo
Placebo
Apremilast 30 mg BID then Apremilast 30 mg BID
Participants received apremilast 30 mg as oral tablets BID for up to 16 weeks (Week 0 to Week 16). Participants who completed the placebo-controlled phase entered the active-treatment phase and received apremilast 30 mg as oral tablets BID for up to an additional 16 weeks (Week 16 to Week 32).
Apremilast
Apremilast
Interventions
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Apremilast
Apremilast
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Subject has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
2. Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
3. Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
4. Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.
Exclusion Criteria
1. Subject has a diagnosis of plaque-type psoriasis.
2. Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
3. Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
4. Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
5. Subject has periodontitis obviously requiring treatment at screening.
6. Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.
7. Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.
8. Subject is pregnant or breastfeeding.
20 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Ichinomiya, Aichi-ken, Japan
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Hitachi, Ibaraki, Japan
Research Site
Sagamihara-shi, Kanagawa, Japan
Research Site
Yokohoma-shi, Kanagawa, Japan
Research Site
Yokosuka, Kanagawa, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Chiyoda-ku, Tokyo, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Itabashi-ku, , Japan
Research Site
Kisarazu, , Japan
Research Site
Kofu, , Japan
Research Site
Minokamo, , Japan
Research Site
Nankoku-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Shinjyuku-ku, , Japan
Research Site
Tōon, , Japan
Research Site
Tsu, , Japan
Countries
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References
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Terui T, Okubo Y, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Uehara N, Handa T, Tanaka M, Zhang W, Paris M, Murakami M. Efficacy and Safety of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: Results from a Phase 2, Randomized, Placebo-Controlled Study. Am J Clin Dermatol. 2023 Sep;24(5):837-847. doi: 10.1007/s40257-023-00788-2. Epub 2023 May 26.
Okubo Y, Terui T, Kobayashi S, Sano S, Morita A, Imafuku S, Tada Y, Abe M, Yaguchi M, Kimura T, Shimauchi J, Zhang W, Amouzadeh H, Murakami M. Exploratory Efficacy Evaluation of Apremilast for the Treatment of Japanese Patients with Palmoplantar Pustulosis: 32-Week Results from a Phase 2, Randomized, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2024 Jul;14(7):1863-1873. doi: 10.1007/s13555-024-01195-z. Epub 2024 Jun 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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U1111-1236-1239
Identifier Type: OTHER
Identifier Source: secondary_id
CC-10004-PPP-001
Identifier Type: -
Identifier Source: org_study_id
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