An extension study to learn if Bimekizumab is safe and works as a long-term therapy in adults with moderate to severe hidradenitis suppurativa

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

23 Jun 2021 → 15 Jan 2026

Decision date (initial)

2024-08-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511035-10-00

EudraCT number

2020-004179-42

WHO UTN

U1111-1307-6132

ClinicalTrials.gov

NCT04901195

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Others, Therapy, Pharmacokinetic, Pharmacoeconomic, Efficacy, Safety

Evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)

Secondary objectives 2

1. Evaluate the safety of long-term therapy of bimekizumab using other safety measures in study participants with moderate to severe HS
2. Evaluate the long-term efficacy of bimekizumab dose regimens on Hidradenitis Suppurativa Clinical Response (HiSCR), other HS scores, and other clinical measures of disease activity in study participants with moderate to severe HS

Conditions and MedDRA coding

Hidradenitis Suppurativa

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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.
2. 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.
3. 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).
4. In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.

Exclusion criteria 6

1. 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).
2. 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.
3. Study participant has a positive or indeterminate interferon-gamma release assay (IGRA) in a feeder study, unless appropriately evaluated and treated.
4. Study participant has ongoing or planned use of prohibited hidradenitis suppurativa (HS) or non-HS treatment.
5. Study participant plans to participate in another study of a medicinal product or device under investigation during this study.
6. In France and in Germany, at the time of implementation of Protocol Amendments 2.3/France and 2.4/Germany, respectively, and after the participant provides informed consent, eligible participants will continue for an additional 48‑week open‑label treatment period if the criteria specified in the Protocol are met. In France, Protocol Amendment 2.6/France has further extended the open-label treatment period for up to 40 additional weeks.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 7

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 10

Locations

9 EU/EEA countries · 44 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 76 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications