臨床研究等提出・公開システム

A Phase 3, Open-label, Parallel Group, Multicenter, Extension Study Evaluating the Long-term Treatment of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa

A study to test the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (BE HEARD EXTENSION)

Matano Mizuho

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR-JRCT.UCBJapan@ucb.com

Global Clinical Science & Operation

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Not Recruiting

July. 28, 2021

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

- Study participant has completed the Maintenance Treatment Period through Week 48 in HS0003 (NCT04242446) or HS0004 (NCT04242498), was eligible to receive bimekizumab at the time of completing the feeder study, and did not meet any withdrawal criteria of the feeder study
- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
- A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
a) Not a woman of childbearing potential (WOCBP) OR
b) A WOCBP who agrees to follow the contraceptive guidance during the open-label extension period and for at least 20 weeks after the final dose of investigational medicinal product (IMP)

- Female study participant who is breastfeeding, pregnant, or plans to become pregnant during the study or within 20 weeks following the final dose of investigational medicinal product (IMP)
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments

Note: For any study participant with an ongoing serious adverse event (SAE) from HS0003 (NCT04242446) or HS0004 (NCT04242498), or any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry or a history of serious infections in HS0003 or HS0004, the Medical Monitor must be consulted prior to the study participant's entry into HS0005, although the decision on whether to enroll the participant remains with the Investigator.
- Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated
- Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment
- Study participant plans to participate in another study of a medicinal product or device under investigation during this study

Both

Hidradenitis suppurativa

bimekizumab 320mg administered by sc injection.

Percentage of participants with treatment-emergent adverse events (TEAEs) during the study.

- Percentage of participants with treatment-emergent serious adverse events (SAEs) during the study
- Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study
- Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50)
- Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)
- Percentage of participants with Flare
- Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Worst Pain
- Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

+81-52-851-5511

June. 22, 2021

Yes

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

America/Australia/Belgium/Bulgaria/Canada/Czech Republic/Denmark/France/Germany/Greece/Hungary/Ireland/Israel/Italy/Netherlands/Norway/Poland/Spain/Switzerland/Turkey/United Kingdom