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

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ClinicalTrials.gov Identifier: NCT04057937
Recruitment Status : Not yet recruiting
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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.


Condition or disease Intervention/treatment Phase
Palmoplantaris Pustulosis Drug: Apremilast Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Japanese Subjects With Palmoplantar Pustulosis
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : March 1, 2021


Arm Intervention/treatment
Experimental: 30 mg Apremilast twice daily (BID) from week 0 to 32
Subject will received Apremilast 30 mg BID from Week 0 to Week 32 weeks. Dose titration will be implemented in the first week of this study.
Drug: Apremilast
Apremilast
Other Name: CC-10004

Placebo Comparator: Placebo and Apremilast
Subject will receive Placebo BID from Week 0 to Week 16 and will receive 30 mg Apremilast BID from week 16 to 32. Dose titration will be implemented in the first week of subject switch to receive Apremilast.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of subjects who achieve a PPPASI- 50 at Week 16 [ Time Frame: Week 16 ]
    The PPPASI is a system used for assessing and grading the severity and area of palmoplantar pustulosis lesions. PPPASI-50 is defined as ≥50 % improvement in PPASI score from Baseline


Secondary Outcome Measures :
  1. Proportion of subjects who achieve a PPPASI. [ Time Frame: up to week 14 ]
    PPPASI-75 is defined as ≥75 % improvement in PPASI score from Baseline.

  2. Proportion of subjects who achieve a PPPASI- 75. [ Time Frame: up to 16 weeks ]
    PPPASI-75 is defined as ≥75 % improvement in PPASI score from Baseline.

  3. Area under the curve (AUC) of PPPASI total score [ Time Frame: Week 0-16 ]
    The PPPASI is a system used for assessing and grading the severity and area of palmoplantar pustulosis lesions.

  4. Percent change from baseline of PPPASI total score [ Time Frame: up to 16 weeks ]
    The PPPASI is a system used for assessing and grading the severity and area of palmoplantar pustulosis lesions.

  5. AUC of Palmo-Plantar Pustulosis (PPSI) total score [ Time Frame: Week 0-16 ]
    The PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12

  6. Percent change from baseline of PPSI total score [ Time Frame: up to 16 weeks ]
    The PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12

  7. Change from baseline of Physician' s Global Assessment (PGA) score [ Time Frame: Up to Week 16 ]
    The PGA for palms and soles is used to determine the subject's palmoplantar pustulosis lesions.

  8. Proportion of subjects who achieve a PGA score of cleared (0) or minimal (1) [ Time Frame: up to 16 weeks ]
    The title expressed the assessment. We don't need extra description.

  9. Proportion of subjects who achieve a PGA score of cleared (0) or minimal (1) and have at least a 2-grade improvement [ Time Frame: Up to 16 weeks ]
    The PGA for palms and soles is used to determine the subject's palmoplantar pustulosis lesions (palms and soles) at a given time point.

  10. Subject's VAS assessment for PPP symptoms [ Time Frame: Up to 16 weeks ]
    Subject assesses a degree of pruritus and pain as symptoms on hands and feet caused by PPP. Worst status by a subject's impression between visits will be recorded.

  11. Adverse Events (AEs) [ Time Frame: 36 weeks (40 weeks at maximum) ]
    Number of participants with adverse event



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  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:

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

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057937


Contacts
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Contact: Natsuka ashiro +81 3-5224-0562 ntashiro@celgeme.com

Locations
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Japan
Fukuoka University Hospital Not yet recruiting
Fukuoka-shi, Fukuoka, Japan, 814-0180
Teikyo University Hospital Not yet recruiting
Itabashi-ku, Japan, 173-8606
Kochi Medical School Hospital Not yet recruiting
Nankoku-shi, Japan, 783-8505
Nippon Life Hospital Not yet recruiting
Osaka, Japan, 550-0006
Sagamihara National Hospital Not yet recruiting
Sagamihara, Kanagawa, Japan, 252-0392
Sapporo Skin Clinic Not yet recruiting
Sapporo-shi, Hokkaido, Japan, 060-0063
Seibo Hosptial Not yet recruiting
Shinjuku-ku, Japan, 161-8521
Tokyo Medical University Hospital Not yet recruiting
Shinjyuku-ku, Japan, 160-0023
Ehime University Hospital Not yet recruiting
Toon, Japan, 791-0295
Nomura Dermatology Clinic Not yet recruiting
Yokohoma City, Kanagawa, Japan, 221-0825
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Ben Hatano Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04057937     History of Changes
Other Study ID Numbers: CC-10004-PPP-001
U1111-1236-1239 ( Other Identifier: WHO )
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Celgene:
Palmoplantar Pustulosis
CC-10004
Apremilast
Only Japanese
Efficacy
Safety
Phase 2
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Thalidomide
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents