Novartis Pharmaceuticals is sponsoring a clinical research trial for men and women, ages 18-65, with hidradenitis suppurativa (also known as “HS” or “hidradenitis”).
Hidradenitis suppurativa is a chronic skin condition that causes painful bumps (also known as “boils” or “nodules”) underneath the skin, most commonly in the underarms, groin and buttock areas. These bumps can become infected and form pus filled pockets also known as “abscesses”. To learn more about hidradenitis suppurativa, click here. (links to 1.1)
This study is designed to assess the effects of two different investigational study drugs in men and women with moderate to severe HS after 16 weeks of dosing. The study drugs may lower the activity of parts of the immune system that are overactive and cause inflammation and disease in people with HS. It is believed that this may reduce HS signs and symptoms and thus be beneficial for those with HS. The study drugs are:
Iscalimab: 2 injections given subcutaneously (under the skin) once a week for the first 5 doses, and then once every two weeks for another 5 doses
LYS006: 4 capsules taken by mouth twice daily with meals for 16 weeks
The study will be conducted in two distinct groups of participants, also known as “cohorts”.
Cohort A will receive either Iscalimab or placebo
Cohort B will receive either LYS006 or placebo
A placebo contains no active drug and is often referred to as ‘dummy drug’. A placebo is used to ensure that changes in HS signs and symptoms are not happening by chance.
Participants who are eligible for both cohorts will be assigned (by chance) to either cohort. Participants who are only eligible for one cohort will be assigned to that cohort. In each cohort, study participants will have a 1-in-3 (33%) chance of receiving placebo and a 2-in-3 (67%) chance of receiving the active study drug. Participants and study doctors are not able to choose which cohort and study drug a participant is assigned. Participants may only participate in one cohort, not both.
Study doctors and participants will not know whether study drug or placebo is being given to a participant until after the study is finished. However, 2study doctors can find out which study drug was being given if there is an emergency.
The study consists of a screening period of up to 4 weeks, a treatment period of 16 weeks, and a safety follow-up of 12 weeks.
To see if you may be eligible, click here to complete a pre-screening questionnaire. (Links 1.1.3)
Trial participants must meet the following requirements:
Are at least 18 years old and no older than 65 years
Were diagnosed with hidradenitis suppurativa
Weigh at least 110 pounds
Willing and able to attend regular study visits for about seven months
Willing and able to take an investigational drug, either by subcutaneous injection or by mouth, for about 4 months
Must not be pregnant (or planning to become pregnant), or breast feeding
Participants who are eligible and decide to enroll in this trial:
Will not be charged to participate
May receive compensation for time and travel costs
May withdraw from the trial at any time, for any reason
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