Informations générales (source: ClinicalTrials.gov)
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa (Intrepid)
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
juin 2024
décembre 2026
04 juillet 2025
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. This study will
compare lutikizumab versus placebo for the treatment of adult and adolescent participants
with the signs and symptoms of moderate to severe HS .
Lutikizumab is an investigational drug being developed for the treatment of HS. During
Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms.
There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult
and adolescent participants with moderate to severe HS will be enrolled in the study at
approximately 275 sites world wide. During Period 2, participants that were part of the
lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab
treatment arms. Participants that were part of the Placebo arm in Period 1 will start
Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2
lutikizumab treatment arms.
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo
every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in
Period 1 will receive subcutaneous injections of lutikizumab every week or every other
week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will
receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every
week or every other week for 20 weeks.
Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will
continue to receive lutikizumab SC using the same assigned dosing regimen from the end of
Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.
Participants in the US that complete Periods 1 & 2 will have the option to enroll in a
156-week open-label Sub-Study that will assess the long term safety and efficacy of
lutikizumab in a prefilled pen.
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Cabinet medical - Le bateau Blanc /ID# 263465 - 13500 - Martigues - Provence-Alpes-Cote-d Azur - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen (CHU)- Hopital Charles Nicolle /ID# 263995 - 76031 - Rouen - Seine-Maritime - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 263459 - 42270 - St-Priest-en-Jarez - Loire - France | Contact (sur clinicalTrials) | ||||
| Hopital Edouard Herriot /ID# 263456 - 69003 - Lyon - Auvergne-Rhone-Alpes - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Courlancy /ID# 263313 - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as
determined by the investigator (i.e., through medical history and interview of
participant).
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic
areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or
higher at Baseline.
- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as
determined by the investigator (i.e., through medical history and interview of
participant).
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic
areas at Baseline.
- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or
higher at Baseline.
- Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Confirmed positive anti-HIV antibody (HIV Ab) test.
- Evidence of active tuberculosis or meets tuberculosis exclusionary parameter