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ONO-4059 Study in Patients With Steroid-resistant Pemphigus

ConditionsPemphigusSteroid-resistant Pemphigus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

ONO-4059-10:Multicenter, placebo-controlled, randomized, double-blind, Phase 3 study in patients with steroid-resistant pemphigus

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a diagnosis of pemphigus

Patients with a re-increase in the pemphigus disease area index (PDAI) score before oral corticosteroid tapering to 10mg/day of prednisolone (PSL) equivalent

Disqualifiers

Patients with an active infection

Patients with malignancy

Patients with past history of serious allergy or anaphylaxis

Trial design

Design model

Parallel

Treatments tested in this trial

  • ONO-4059

    Drug

    Tirabrutinib is a Bruton's Tyrosine Kinase Inhibitor. Tirabrutinib will be administered orally at a dose of 80 mg once daily after a meal (breakfast, lunch, or dinner).

  • ONO-4059 placebo

    Drug

    Placebo will be administered orally once daily after a meal (breakfast, lunch, or dinner).

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: ONO-4059Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients with a Complete response (CR) or Partial response (PR) at 52 weeks, and maintaining complete/partial remission at 52 weeks from initial remission achievement.

CR: Absence of pemphigus-related blisters or new erythema that lasts for 8 weeks during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy. PR: Occurrence of only a transient lesion that resolves within 1 week without an increased dose of an oral corticosteroids, without treatment, or with a topical corticosteroid, etc., during treatment with ONO-4059 plus an oral corticosteroid (≤10 mg/day prednisolone-equivalent) or minimal adjunctive therapy for 8 weeks.

Time frame
52 weeks

Secondary outcomes

1

Remission rate

remission rate \[proportion of subjects who achieve complete or partial remission\], complete remission rate, partial remission rate

Time frame
52 weeks
2

Pemphigus Disease Area Index (PDAI) score

Pemphigus Disease Area Index (PDAI). PDAI activity score cutoffs were defined as 0 to 8 for mild, 9 to 24 for moderate, and 25 or higher for severe disease.

Time frame
52 weeks
3

Efficacy 1 rate (proportion of subjects for whom the definition of efficacy 1 is applicable)

Definition of efficacy 1: Decreases in PDAI score and oral corticosteroid dose from baseline

Time frame
52 weeks
4

Efficacy 2 rate (proportion of subjects for whom the definition of efficacy 2 is applicable)

Definition of efficacy 2: PDAI score is 0 and oral corticosteroid dose \<= 10 mg/day

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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