BE HEARD Extension Study

Australia, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Spain, Switzerland, Turkey, United Kingdom, United States (ICTRP)

ID di studio ICTRP
EUCTR2020-004179-42 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Eine offene, Parallel-Gruppen, multizentrische Verlängerungsstudie der Phase 3 zur Beurteilung der Langzeitbehandlung mit Bimekizumab bei Studienteilnehmern mit mässiger bis schwerer Hidradenitis suppurativa (BASEC)

Titolo accademico
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 - BE HEARD EXTENSION (ICTRP)

Titolo pubblico
A study to test the long-term treatment of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (ICTRP)

Malattie studiate
Hidradenitis Suppurativa
MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20] (ICTRP)

Intervento studiato

Product Name: Bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BIMEKIZUMAB
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

(ICTRP)

Tipo di studio
Interventional clinical trial of medicinal product (ICTRP)

Disegno dello studio
Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2 (ICTRP)

Criteri di inclusione/esclusione
Gender:
Female: yes
Male: yes

Inclusion criteria:
- 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 822
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
(ICTRP)

Exclusion criteria:
- 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



Endpoint primari e secondari
Main Objective: Evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe Hidradenitis Suppurativa (HS)
;Secondary Objective: - Evaluate the safety of long-term therapy of bimekizumab using other safety measures in study participants with moderate to severe HS
- 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
;Primary end point(s): 1. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
;Timepoint(s) of evaluation of this end point: 1: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 120)
(ICTRP)

Secondary end point(s): 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 Worst Pain
7. Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score
;Timepoint(s) of evaluation of this end point: 1-2: From Baseline (Day 1) until end of Safety Follow-Up (up to Week 120)
3-7: Week 0, Week 16, Week 32, Week 48, Week 76, Week 92, Week 100
(ICTRP)

Data di registrazione
04.08.2021 (ICTRP)

Inclusione del primo partecipante
20.12.2021 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Clin Trial Reg & Results Disclosure, clinicaltrials@ucb.com, UCB BIOSCIENCES GmbH (ICTRP)

ID secondari
HS0005, 2020-004179-42-FR (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004179-42 (ICTRP)