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Title: A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa
Brief Title: Safety and tolerability of remibrutinib in HS
Brief Summary:
For info regarding 2025P000136
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 52-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis (EFC17600)
Brief Title: EFC17600: Ph 3 AD Amlitelemab ESTUARY study
Brief Summary: This is a multinational, multicenter, randomized, double-blind, placebo-controlled,
parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed
with moderate-to-severe atopic dermatitis (AD).
The main objective of this study is to evaluate if those participants who received
amlitelimab dose 1 in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2],
EFC17561 [SHORE]) and were responders can maintain their response either remaining at
dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal.
Study details include:
The study duration will be up to 68 weeks including a 52-week randomized double-blind
period, and a 16-week safety follow-up for participants not entering the LTS17367
(RIVER-AD).
The study duration will be up to 52 weeks for participants entering the LTS17367
[RIVER-AD] study at the Week 52 visit of EFC17600 (ESTUARY).
The total treatment duration will be up to 52 weeks. The total number of visits will be
up to 15 visits (or 14 visits for those entering LTS17367 [RIVER-AD] study).
For info regarding 2025P000030
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 2, Randomized, Double-blind, Placebocontrolled, Parallel-group Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients with Moderate to Severe Hidradenitis Suppurativa (LOTUS)
Brief Title: Evaluate AVTX-009 in adults with hidradenitis suppurativa
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of AVTX-009
compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
For info regarding 2024P000871
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
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
Brief Title: Evaluate Lutikizumab in Adults with Hidradenitis Suppurativa
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. 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.
For info regarding 2024P000711
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa
Brief Title: Evaluate sonelokimab in adults with hidradenitis suppurativa
Brief Summary: This is a study to evaluate the clinical efficacy and safety of sonelokimab administered
subcutaneously compared with placebo in the treatment of adult participants with moderate
to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either
sonelokimab or matching placebo up to Week 16.
For info regarding 2024P000641
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis (EFC17559)
Brief Title: EFC17559: Ph 3 AD Amlitelemab COAST 1 study
For info regarding 2024P000425
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Brief Title: Evaluate Eltrekibart in Adults with Hidradenitis Suppurativa
Brief Summary: This study aims to find the appropriately safe and effective dose and dosing frequency
for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for
further clinical development. The study will last approximately 62 weeks and may include
up to 31 visits.
For info regarding 2024P000158
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy andSafety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe HidradenitisSuppurativa Who Have Failed Anti-TNF Therapy
Brief Title: Abbvie M23-698: Evaluation of Upadacitinib in HS Adults
Brief Summary: Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions
in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This
study will assess how safe and effective upadacitinib is in treating adult and adolescent
participants with moderate to severe HS who have failed to respond to or are intolerant
of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease
activity will be assessed.
Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid
arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the
treatment of HS. This study is "double-blinded", meaning that neither the trial
participants nor the study doctors will know who will be given upadacitinib and who will
be given placebo. This study is comprised of 3 periods. In Period 1, participants are
randomized into 2 groups called treatment arms where each group receives a different
treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In
Period 2, participants are placed into 6 different groups depending on their placement
and results in Period 1. Period 3 is the long-term extension period where participants
will continue treatment from Period 2. Approximately 1328 adult and adolescent
participants diagnosed with HS will be enrolled in approximately 275 sites worldwide.
Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks
in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter
Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks.
Participants will be followed up for approximately 30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular outpatient visits during the study.
The effect of the treatment will be checked by medical assessments, checking for side
effects and completing questionnaires.
For info regarding 2023P000553
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A pilot study evaluating the safety and efficacy of deucravacitinib compared to placebo in the treatment of moderate-to-severe Hidradenitis suppurativa (HS)
Brief Title: Evaluating deucravacitinib in the treatment of HS
For info regarding 2023P000400
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu
Title: A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Topical OA-3, a PAR2 Inhibitor, in Adult Healthy Volunteers and Subjects with Atopic Dermatitis and Pruritus
Brief Title: Phase 1a/1b Study Efficacy of Topical OA-3, a PAR2 Inhibitor
Brief Summary: The purpose of this study is to help us understand the safety and the potential effectiveness a new topical study drug called OA-3 hydrogel for the treatment of atopic dermatitis (AD), or eczema. This study will be open to atopic dermatitis patients and healthy patients.
For info regarding 2023P000228
please contact Martina Porter at 617-667-5834 or
clears@bidmc.harvard.edu