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

Amgen

Status and phase: Completed; Phase 2

Conditions: Palmoplantaris Pustulosis

Treatments: Drug: Placebo; Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT04057937

U1111-1236-1239 (Other Identifier)

CC-10004-PPP-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Placebo then Apremilast 30mg BID

Experimental group

Description:

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).

Treatment:

Drug: Apremilast

Drug: Placebo

Apremilast 30 mg BID then Apremilast 30 mg BID

Experimental group

Description:

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).

Treatment:

Drug: Apremilast