JOURNAL ONKOLOGIE – STUDIE

A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05139602

Studienbeginn:
Dezember 2021

Letztes Update:
16.04.2024

Wirkstoff:
Lutikizumab, Placebo

Indikation (Clinical Trials):
Hidradenitis Suppurativa, Hidradenitis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

ABBVIE CALL CENTER
Kontakt:
Phone: 844-663-3742
E-Mail: abbvieclinicaltrials@abbvie.com» Kontaktdaten anzeigen

Studienlocations
(3 von 54)

Universitaetsklinikum Erlangen /ID# 240872
91054 Erlangen
(Bayern)
GermanyAbgeschlossen» Google-Maps

Havelklinik /ID# 240874
13595 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps

Klinikum Ruhr Univ Bochum /ID# 240870
44791 Bochum
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps

Staedtisches Klinikum Dessau /ID# 240871
06847 Dessau
(Sachsen-Anhalt)
GermanyAbgeschlossen» Google-Maps

Universitaetsklinikum Hamburg-Eppendorf /ID# 240873
20246 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-Maps

Medical Dermatology Specialists /ID# 240641
85006 Phoenix
United StatesRekrutierend» Google-Maps

Mayo Clinic - Scottsdale /ID# 241030
85259-5452 Scottsdale
United StatesRekrutierend» Google-Maps

Burke Pharmaceutical Research /ID# 240811
71913-6404 Hot Springs
United StatesAbgeschlossen» Google-Maps

UCSF Fresno /ID# 240903
93701-2302 Fresno
United StatesAbgeschlossen» Google-Maps

Medderm Associates /ID# 240729
92103 San Diego
United StatesAbgeschlossen» Google-Maps

Clinical Trials Research Institute /ID# 240642
91320-2130 Thousand Oaks
United StatesRekrutierend» Google-Maps

CCD Research, PLLC /ID# 240728
06416-1745 Cromwell
United StatesAbgeschlossen» Google-Maps

Skin Care Research - Boca Raton /ID# 240758
33486-2269 Boca Raton
United StatesRekrutierend» Google-Maps

Apex Clinical Trials /ID# 248558
33511 Brandon
United StatesRekrutierend» Google-Maps

GSI Clinical Research, LLC /ID# 240901
33063 Margate
United StatesAbgeschlossen» Google-Maps

Florida International Rsrch cr /ID# 240902
33173 Miami
United StatesAbgeschlossen» Google-Maps

Park Avenue Dermatology, PA /ID# 240807
32073 Orange Park
United StatesAbgeschlossen» Google-Maps

TruDerm Dermatology of Wellington /ID# 240780
33449 Wellington
United StatesAbgeschlossen» Google-Maps

Dawes Fretzin, LLC /ID# 240701
46256 Indianapolis
United StatesRekrutierend» Google-Maps

Beth Israel Deaconess Medical Center /ID# 240683
02215-5400 Boston
United StatesRekrutierend» Google-Maps

Revival Research Institute, LLC /ID# 241020
48084-3536 Troy
United StatesAbgeschlossen» Google-Maps

MediSearch Clinical Trials /ID# 240810
64506 Saint Joseph
United StatesRekrutierend» Google-Maps

Washington University-School of Medicine /ID# 240797
63110 Saint Louis
United StatesRekrutierend» Google-Maps

Advanced Dermatology of the Midlands /ID# 249750
68144-1105 Omaha
United StatesAbgeschlossen» Google-Maps

Skin Specialists, PC /ID# 240804
68144 Omaha
United StatesAbgeschlossen» Google-Maps

Psoriasis Treatment Center of Central New Jersey /ID# 240900
08520 East Windsor
United StatesRekrutierend» Google-Maps

Montefiore Medical Center /ID# 240853
10467 Bronx
United StatesAbgeschlossen» Google-Maps

Mount Sinai Doctors Dermatology /ID# 241588
10029-6504 New York
United StatesAbgeschlossen» Google-Maps

Essential Medical Research, LLC /ID# 241807
74137-2842 Tulsa
United StatesRekrutierend» Google-Maps

Center for Clinical Studies - Houston (Binz) /ID# 240692
77004-8097 Houston
United StatesAbgeschlossen» Google-Maps

Duplicate_Paratus Clinical Research Woden /ID# 240605
2606 Phillip
AustraliaAbgeschlossen» Google-Maps

Holdsworth House Medical Practice /ID# 240911
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps

Premier Specialist /ID# 241288
2217 Kogarah
AustraliaRekrutierend» Google-Maps

Veracity Clinical Research /ID# 241096
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps

Beacon Dermatology Inc /ID# 240741
T3A 2N1 Calgary
CanadaRekrutierend» Google-Maps

Wiseman Dermatology Research /ID# 240738
R3M 3Z4 Winnipeg
CanadaRekrutierend» Google-Maps

Lima's Excellence in Allergy and Dermatology Research Inc /ID# 240814
L8L 3C3 Hamilton
CanadaRekrutierend» Google-Maps

SKDS Research /ID# 247986
L3Y 5G8 Newmarket
CanadaRekrutierend» Google-Maps

Dre Angelique Gagne-Henley M.D. inc. /ID# 240739
J7Z 7E2 Saint-Jerome
CanadaRekrutierend» Google-Maps

401 GSNA - 401 Army General Hospital /ID# 242189
11527 Athens
GreeceAbgeschlossen» Google-Maps

University General Hospital Attikon /ID# 240371
12462 Athens
GreeceAbgeschlossen» Google-Maps

General Hospital Andreas Syggros /ID# 241104
16121 Athens
GreeceAbgeschlossen» Google-Maps

Duplicate_Papageorgiou General Hospital Thessaloniki /ID# 240385
55536 Stavroupoli (Thessalonikis)
GreeceAbgeschlossen» Google-Maps

General Hospital of Thessaloniki Hippokrateio /ID# 240697
54642 Thessaloniki
GreeceAbgeschlossen» Google-Maps

Nagoya City University Hospital /ID# 244392
467-8602 Nagoya shi
JapanAbgeschlossen» Google-Maps

Fukuoka University Hospital /ID# 244390
814-0180 Fukuoka-shi
JapanAbgeschlossen» Google-Maps

University Hospital Kyoto Prefectural University of Medicine /ID# 244739
602-8566 Kyoto-shi
JapanAbgeschlossen» Google-Maps

University of the Ryukyus Hospital /ID# 244848
903-0215 Nakagami-gun
JapanAbgeschlossen» Google-Maps

Kindai University Hospital /ID# 245358
589-8511 Osakasayama-shi
JapanAbgeschlossen» Google-Maps

Alma M. Cruz Santana, MD-Private practice /ID# 244514
00985 Carolina
Puerto RicoRekrutierend» Google-Maps

Hospital de Manises /ID# 240440
46940 Manises
SpainAbgeschlossen» Google-Maps

Hospital Santa Creu i Sant Pau /ID# 240529
08041 Barcelona
SpainAbgeschlossen» Google-Maps

Hospital Universitario Virgen de las Nieves /ID# 240429
18014 Granada
SpainAbgeschlossen» Google-Maps

Hospital General Universitario Gregorio Maranon /ID# 240396
28007 Madrid
SpainAbgeschlossen» Google-Maps

Alle anzeigen

Studien-Informationen

Brief Summary:

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which

includes the forming of lumps, abscesses and scars in areas of the skin such as under the

breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit

anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a

significant unmet medical need for patients who fail to achieve adequate benefit with

anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the

treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy.

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. In

the Main Study, participants will be put in 1 of 4 groups, called treatment arms. There is a

1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants

with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at

approximately 50 sites worldwide. In the Sub-study, participants will be put in 1 of 2

groups, called treatment arms. Both arms will receive treatment at different dosing

intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic

therapy will be enrolled in the study at certain sites.

In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981)

or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous

injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week

or every other week for 36 weeks.

There may be higher treatment burden for participants in this trial compared to their

standard of care. Participants will attend regular visits during the study at a hospital or

clinic. The effect of the treatment will be checked by medical assessments, blood tests,

checking for side effects and completing questionnaires and diaries.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to

Baseline as determined by the investigator.

- A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline

- HS lesions must be present in at least 2 distinct anatomic areas.

- Must have failed anti-TNF treatment for HS.

- To be eligible for the Sub-study, participants must be naïve to biologic therapy for

treatment of HS.

Exclusion Criteria:

- History of active skin disease other than HS that could interfere with the assessment of

HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic

treatment within 4 weeks of the Baseline visit.

Studien-Rationale

Primary outcome:

1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) (Time Frame - Week 16):
HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula-count relative to Baseline.

2. Number of Participants with Adverse Events (AEs) (Time Frame - Up to Approximately Week 68):
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcome:

1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 (Time Frame - Week 16):
NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain.

Studien-Arme

Experimental: Main Study: Lutikizumab Dose A
Lutikizumab Dose A every week
Experimental: Main Study: Lutikizumab Dose B
Lutikizumab Dose B every other week
Experimental: Main Study: Lutikizumab Dose C
Lutikizumab Dose C every other week
Placebo Comparator: Main Study: Placebo
Placebo every week
Experimental: Sub-study: Group 1
Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Experimental: Sub-study: Group 2
Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

Geprüfte Regime

Lutikizumab (ABT-981):
Subcutaneous Injection
Placebo:
Subcutaneous Injection

Quelle: ClinicalTrials.gov

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"A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy"

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