Lutikizumab in Adult & Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa
Research type
Research Study
Full title
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
IRAS ID
1010072
Contact name
Hannah Wainmann
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-510730-40
Clinicaltrials.gov Identifier
Research 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. This study will compare lutikizumab versus placebo for the treatment
of adult and adolescent participants with 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
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.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0655
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion