A multicentre, randomised, double-blind, placebo-controlled, parallel-group, investigators initiated phase III clinical trial to evaluate the efficacy of IDEC-C2B8 in patients with steroid treatment-resistant bullous pemphigoid.

JRCT ID: jRCT2031240107

Registered date:24/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: bullous pemphigoid
• Date of first enrollment: 26/06/2024
• Target sample size: 60
• Study type: Interventional

Intervention(s)

Patients with steroid treatment-resistant bullous pemphigoid will be randomized at enrollment to Group A-1, Group A-2, Group B-1 or Group B-2 in a 1:1:1 ratio. This study consists of the first period with Group A [Group A-1 (IDEC-C2B8) and Group A-2 (IDEC-C2B8)] and Group B [Group B-1 (placebo) and Group B-2 (placebo)] for the first 24 weeks, and the late period with Group A-1 (IDEC-C2B8), Group A-2 (placebo) and Group B [Group B-1 (IDEC-C2B8) and Group B-2 (IDEC-C2B8)] for further 24 weeks (48 weeks in total) to evaluate the efficacy and safety of IDEC-C2B8. IDEC-C2B8 1,000 mg/body or placebo will be administered intravenously twice at 2-week intervals during the first period (0W: Day 0, 2W: Day 14) and the second period (0W: Day 0, 2W: Day 14). During both first and second periods, study drug will be administered in a double-blind fashion.
However, after all subjects have completed the first period and the key has been opened, the blinded groups A (groups A-1 and A-2) will remain blinded and group B will be unblinded.
The PSL dose in the first period will be reduced in accordance with protocol.

Outcome(s)

• Primary Outcome: Percentage of subjects achieving maintenance of remission at 24 weeks of the previous period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old

Include criteria

1) Patients with a confirmed diagnosis of bullous pemphigoid treated with PSL and his/her BPDAI (skin: blister/erosion) score increased again until PSL was reduced to 10 mg/day.
[BPDAI (skin: blister/erosion) score of 1 at the time of obtaining consent]
2) Patients with 3 or more new lesions (bullae, eczematous lesions, urticaria-like erythema) or new lesions larger than 10 cm (eczematous lesions, urticaria-like erythema) per month that do not resolve spontaneously within 1 week, or enlargement of existing lesions or enhancement of daily itching, from 3 months prior to obtaining consent to the time of consent
3) Patients with anti-BP180NC16a IgG antibodies higher than the reference level
4) Patients treated with PSL 15-30 mg/day at the time of consent and no need for PSL dose change during the screening period
5) Patients who have been fully informed about the study and who have given their written consent to participate in the study.

Exclude criteria

1) Patients with a BPDAI (skin: blister/erosion) score increase of at least 14 points at two time points at least 7 days apart during the screening period
2) Pregnant or lactating women, women who may be pregnant, women of childbearing potential who do not wish to use a highly effective contraceptive method during the study period and for 6 months after completion of the study, or men who are partners of women of childbearing potential who do not wish to use a highly effective contraceptive method during the study period and for 6 months after completion of the study
3) Patients with a history of hypersensitivity or shock to humanized or murine antibodies or murine-derived components
4) Patients with serious and uncontrollable organ damage
5) Patients with diseases other than pemphigoid requiring systemic administration of steroids (e.g., asthma, Crohn's disease) within 12 weeks prior to the start of screening

Related Information

• Primary Sponsor: Takahashi Hayato
• Source(s) of Monetary Support: Zenyaku Kogyo Co., Ltd.