Informations générales (source: ClinicalTrials.gov)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Proof-of-concept Study Assessing the Efficacy and Safety of Amlitelimab in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Interventional
Phase 2
Sanofi (Voir sur ClinicalTrials)
novembre 2023
janvier 2027
05 avril 2025
This is a parallel, Phase 2, 2-arm, double-blind, randomized, multicenter, multinational,
placebo-controlled study to evaluate efficacy, safety, pharmacokinetics (PK), and
biological effects of treatment of subcutaneous injection of amlitelimab compared with
placebo in male and female participants aged 18 to 70 years with moderate to severe
hidradenitis suppurativa (HS).
The purpose of this study is to measure standardized clinician reported and
participant-reported outcomes (ClinRO and PRO), safety, and drug concentration. An
optional long-term extension (LTE) period will assess chronic safety and efficacy over an
additional 80 weeks of amlitelimab treatment.
Study details include:
- The study duration will be up to 116 weeks, including a 4-week Screening period, a
16-week double-blind treatment period (DBT), an optional 80-week LTE period and a
16-week post-treatment follow-up period.
- All participants who complete the 16-week DBT period will be offered entry into an
optional LTE.
- Participants who do not wish to enter the optional LTE period or who stop treatment
prior to Week 16 (Visit 6) or stop investigational medicinal product (IMP)
administration prior to completing the LTE period will proceed into the 16-week
post-treatment follow-up period.
- The number of planned in clinic visits will be up to six during the DBT period with
an additional nine during the LTE period, plus one post-treatment follow-up
end-of-study visit. Up to 11 optional in clinic visits are allowed for participants
who do not wish to self-administer IMP between scheduled in clinic visits during the
LTE period.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HIA BEGIN | 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 | |||||
| Investigational Site Number : 2500001 - 51100 - Reims - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500003 - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500004 - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 17019 - La Rochelle - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participant must be 18 (or country's age of majority if >18) years to 70 years of
age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1
year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg,
left, and right axilla; or left axilla and left inguino-crural fold), 1 of which
must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an
oral antibiotic for treatment of HS
- Participant must be 18 (or country's age of majority if >18) years to 70 years of
age inclusive, at the time of signing the informed consent.
- Participants with a history of signs and symptoms consistent with HS for at least 1
year prior to baseline.
- Participants must have HS lesions present in at least 2 distinct anatomic areas (eg,
left, and right axilla; or left axilla and left inguino-crural fold), 1 of which
must be Hurley Stage II or Hurley Stage III.
- Participant must have had an inadequate response to at least a 12-week trial of an
oral antibiotic for treatment of HS
- Participants with a diagnosis of inflammatory conditions other than HS (including
but not limited to systemic lupus erythematosus, systemic sclerosis, myositis,
rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis,
multiple sclerosis, Behcet's disease, sarcoidosis, etc)
- Any other active skin disease or condition (eg, bacterial, fungal, or viral
infection) that may interfere with assessment of HS
The above information is not intended to contain all considerations relevant to a
potential participation in a clinical trial