Hidradenitis suppurativa MedDRA version: 20.0 Level: LLT Classification code 10076650 Term: Acne inversa System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Ilumetri 100 mg Injektionslösung in einer Fertigspritze
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tildrakizumab
CAS Number: 1326244-10-3
Concen
Sponsors
University Medical Center of the Johannes Gutenberg- University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Moderate to severe HS for at least 1 year (365 days) prior to the baseline visit 3. Stable HS for at least 1 month (28 days) prior to the first study visit 4. HS lesions present in at least one distinct anatomic area 5. History of an inadequate response to an antibiotics treatment of HS 6. Total abscess and inflammatory nodule (AN) count of =3 at the screening and first study visit 7. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Any other active skin disease or condition that could interfere with assessment of HS 2. Investigational findings or clinical history that rule out treatment with tTildrakizumab (such as tuberculosis, HIV, hepatisis, mycobacterial infection) 3. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 4. Is under therapy with any medication that effects the sleep (e.g. antidepressants) 5. Receipt of therapies that may interfere with with tTildarakizumab treatment or with assessment of HS 6. Is pregnant, nursing, or planning a pregnancy (both men and women) while enrolled in the study or within 12 weeks following the last administration of tTildarakizumab 7. Suicidal ideation or suicidal behavior in the last 6 months, substance abuse (drug or alcohol) disorder within the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the initial efficacy of Tildrakizumab in adult participants with moderate to severe HS at Week 20.;Secondary Objective: • to evaluate the efficacy of Tildrakizumab on other measures of disease activity in study participants with moderate to severe HS • to evaluate the efficacy of Tildrakizumab on HiSCR, other HS Scoresscores, and other clinical measures of disease activity at various timepoints in study participants with moderate to severe HS • to evaluate the efficacy of Tildrakizumab on abscesses, nodules, and draining tunnels at various timepoints in study participants with moderate to severe HS • to evaluate the efficacy of Tildrakizumab on patient-reported outcome measures at various timepoints in study participants with moderate to severe HS • to evaluate the changes in pathology of Tildrakizumab in study participants with moderate to severe HS • to evaluate the sleep pattern of the patients before, during and after therapy initiation. • to evaluate change of physical activity during the study ;Primary end point(s): HiSCR50 at Week 20;Timepoint(s) of evaluation of this end point: Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Absolute change from Baseline in DLQI Total Score at Week 20 - Absolute change from Baseline in International Hidradenitis Suppurativa Severity Score System at Week 20 - Absolute and percentage change from Baseline in CRP at Week 20 - HiSCR25, HiSCR75, HiSCR90, and HiSCR100 at Week 20 - Absolute and percentage change (worst and average pain) from Baseline in HS Skin Pain score (11-point numeric rating scale) at Week 20 - Absolute change from Baseline in DLQI Total Score at Week 20 - Absolute change from Baseline IPQA Total Score at Week 20 - Absolute change from Baseline PSQI Total Score at Week 20 - Absolute change from Baseline ISI Total Score at Week 20 - Absolute change from Baseline MOS-SS Total Score at Week 20 - Absolute change from Baseline ESS Total Score at Week 20 - Absolute change from Baseline in vital signs at Week 20 - Absolute change from Baseline in Hidradenitis Suppurativa Physician’s Global Assessment at Week 20 - Absolute change from Baseline in PGI-S-HS at Week 20 - Absolute change from Baseline in PGI-C-HS at Week 20 - Absolute change from Baseline in BMI at Week 20 - Absolute change from Baseline in clinical laboratory values (chemistry and hematology) at Week 20 - Changes in inflammatory activity and severity of acne inversa in histopathological analyses at Week 20 - Sleep disturbances - Safety and tolerability of Tildrakizumab: Analysis of adverse events and laboratory data;Timepoint(s) of evaluation of this end point: Week 20 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. med. Petra Staubach-Renz
University Medical Center of the Johannes Gutenberg- University Mainz
Outcome results
None listed