Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid

JRCT ID: jRCT2071210034

Registered date:17/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mild to moderate bullous pemphigoid
• Date of first enrollment: 12/10/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Patients will be orally taking ART-648 2 mg in the evening of Day 1, 2 mg twice daily on Day 2 and 3, and 4 mg twice daily from Day 4 or later.

Outcome(s)

• Primary Outcome: Proportion of patients achieving the cessation of new lesion formation (erosion/blister or wheal/erythema) without rescue therapy at week 4.

Secondary Outcome

Efficacy
Proportion of patients achieving the cessation of new lesion formation (erosion/blister or sheal/ erythema) without rescue therapy at week 2.
Change from basline to week 2 and 4 in BPDAI score
Change from basline to week 2 and 4 in pruritus VAS score
Proportion of patients receiving rescue therapy at week 2 and 4
Safety
Frequency and severity of adverse events
Pharmacokinetics
Plasma ART-648 concentrations

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) All sexes, 20 years old and older
2)Patients with mild to moderate bullous pemphigoid (BP) who meet the following 1 or 2
1 Patients satisfied with one or all items of A and both B-1 and B-2- (2) and distinguished from the diseases listed in C.
2 Patients satisfied with one or all items of A, two of B-2, and distinguished from the diseases listed in C.
A: Clincal diagnosis
1. Cutaneous tense bullae and erosions
2. Cutaneous itchy erythema on the skin
B: Laboratory diagnosis
1. Histopathology
(1) Subepidermal blisters are observed
2. Immunology
(1) IgG or complement deposits are observed on the basement membrane of the epidermis of the skin by the direct fluorescent antibody method.
(2) Detect anti-BP180 antibody (IgG) in blood by ELISA (CLEIA) method
C: Differential diagnosis
Differentiate from the following diseases. Mucosal pemphigoid, acquired epidermolysis bullosa, epidermolysis bullosa, insect bites, urticaria-like vasculitis, porphyria, erythema multiforme, drug eruption, amyloid-sis, blistering erythematosus
3) Patients with a total BPDAI score in the range of 10-40 at screening
4) Patients who are judged by the investigator to be able to visit the hospital according to the examination/observation schedule and carry out examination/evaluation of the clinical trial, including observation of the skin condition of the whole body.
5) Patients who understand the method and compliance items of this clinical trial and voluntarily agree to the participation in this clinical trial with written consent.

Exclude criteria

1) Patients with clinically significant medical condition, mental condition, or medical history which the investigator judges to interfere the subject's ability to participate in the clinical trial or determines that participation in the clinical trial increases the risk of the subject.
2) Patients with BP resistant to oral steroid or IVIG therapy
3) Patients with suspected drug-induced BP
4) Patients with prior treatment for immunosuppressants, IVIG, plasmapheresis or steroid pulse therapy
5) Patients with skin diseases that interfere with the evaluation of BP
6) Patients with a history of prior treatment with prohibited drugs within the prescribed period before the start of study drug administration
7) Patients who have been previously treated with biologics and have not passed more than 5 times the T1 / 2 period of the drug used at screening.
8) Patients who participated in other clinical trials (excluding observational studies)
9) Patients who disagree with contraception
10) Pregnant or lactating female patients
11) Patients who are judged by the investigator to be not eligible for the clinical trial

Related Information

• Primary Sponsor: Nagabukuro Hiroshi