A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis

NCT04057937 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CC-10004-PPP-001U1111-1236-1239
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 22

Brief Summary

This study will evaluate whether apremilast is better than placebo (inactive substance in the same form as the drug) for the treatment in Japanese subjects with PPP. This study also will evaluate the safety and tolerability of apremilast in Japanese subjects with PPP.CC-10004-PPP-001 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 2 study of apremilast in Japanese subjects with PPP and inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations. 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.

Conditions

Palmoplantaris Pustulosis

Keywords

Palmoplantar Pustulosis; CC-10004; Apremilast; Only Japanese; Efficacy; Safety; Phase 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve a PPPASI-50 at Week 16

  PPPASI-50 is defined as \>= 50 percent decrease in PPPASI total score from baseline. PPPASI is a disease-specific efficacy assessment tool to evaluated for 3 signs of the disease (erythema, pustules/vesicle and desquamation/scale) as sub-scores on palms or soles. The PPPASI total scores are calculated by sum of the sub-scores and range from 0 to 72 with a higher score indicating more severe disease.

  At Week 16

Secondary Outcomes (11)

• Percentage of Participants Who Achieve a PPPASI-50 at All Other Visits in Placebo-controlled Phase

  Weeks 2 to 14

• Percentage of Participants Who Achieve a PPPASI-75 at Each Visit in Placebo-controlled Phase

  Weeks 2 to 16

• Area Under the Curve (AUC) of PPPASI Total Score From Baseline Through Week 16

  Baseline to Week 16

• Percent Change From Baseline in PPPASI Total Score by Visit in Placebo-controlled Phase .

  Baseline to Week 16

• Change From Baseline in PPPASI Total Score at Week 16

  Baseline and Week 16

Study Arms (2)

Placebo then Apremilast 30mg BID

EXPERIMENTAL

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).

Drug: Apremilast; Drug: Placebo

Apremilast 30 mg BID then Apremilast 30 mg BID

EXPERIMENTAL

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).

Drug: Apremilast

Interventions

Apremilast DRUG

Apremilast

Also known as: CC-10004

Apremilast 30 mg BID then Apremilast 30 mg BID; Placebo then Apremilast 30mg BID

Placebo DRUG

Placebo

Placebo then Apremilast 30mg BID

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 has a diagnosis of Palmoplantar Pustulosis with or without pustulotic arthro-osteitis (PAO) for at least 24 weeks before screening.
• Subject has a total score of PPPASI: ≥ 12 at screening and baseline.
• Subject has moderate or severe pustules/vesicles on palms or soles (PPPASI severity score: ≥ 2) at screening and baseline.
• Subject has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations prior to or at screening.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has a diagnosis of plaque-type psoriasis.
• Subject has the presence of pustular psoriasis in any part of the body other than the palms and soles.
• Subject has obvious improvement during screening (≥ 5 PPPASI total score improvement during the screening).
• Subject has received any procedures for focal infection (e.g, tonsillectomy and dental therapy) within 24 weeks of baseline.
• Subject has periodontitis obviously requiring treatment at screening.
• Subject has chronic or recurrent tonsillitis or sinusitis requiring any continuous treatment for a month or more at screening.
• Subject has evidence of skin conditions of hands and feet that would interfere with evaluations of the effect of study medication.
• Subject is pregnant or breastfeeding.

Sponsors & Collaborators

• Amgen: lead

Study Sites (22)

Research Site

Ichinomiya, Aichi-ken, 491-8558, Japan

Location

Research Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Research Site

Fukuoka, Fukuoka, 814-0180, Japan

Location

Research Site

Sapporo, Hokkaido, 060-0063, Japan

Location

Research Site

Hitachi, Ibaraki, 317-0077, Japan

Location

Research Site

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Research Site

Yokohoma-shi, Kanagawa, 221-0825, Japan

Location

Research Site

Yokosuka, Kanagawa, 238-8558, Japan

Location

Research Site

Izumo, Shimane, 693-8501, Japan

Location

Research Site

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Research Site

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Research Site

Itabashi-ku, 173-8610, Japan

Location

Research Site

Kisarazu, 292-8535, Japan

Location

Research Site

Kofu, 400-0027, Japan

Location

Research Site

Minokamo, 505-8503, Japan

Location

Research Site

Nankoku-shi, 783-8505, Japan

Location

Research Site

Osaka, 550-0006, Japan

Location

Research Site

Sendai, 980-8574, Japan

Location

Research Site

Shinjuku-ku, 161-8521, Japan

Location

Research Site

Shinjyuku-ku, 160-0023, Japan

Location

Research Site

Tōon, 791-0295, Japan

Location

Research Site

Tsu, 514-8507, Japan

Location

Related Publications (2)

• 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.

  PMID: 37233897 BACKGROUND

• 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.

  PMID: 38896381 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: October 16, 2019
• Primary Completion: January 18, 2021
• Study Completion: June 7, 2021
• Last Updated: July 17, 2024
• Results First Posted: January 6, 2022

Record last verified: 2024-07

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

JP (22)