LUTIKIZUMAB for Hidradenitis suppurativa

Inclusion criteria

• {"criterion_text":"- Subjects must be ≥12 years of age (or ≥16 in countries where <16 is not permitted, or ≥18 in countries where <18 is not permitted) at the screening visit.\n- Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of subject).\n- Total AN count of ≥ 5 at Baseline.\n- HS lesions present in at least two distinct anatomic areas at Baseline.\n- At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.\n- Subjects must have had an inadequate response per investigator's judgement to a 12-week trial (or an adequate trial per local treatment guidelines) of oral antibiotics for treatment of HS or demonstrated intolerance to oral antibiotics for HS treatment."}

Exclusion criteria

• {"criterion_text":"- Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: •\tSerum AST > 2 × ULN; •\tSerum ALT > 2 × ULN; •\tSerum total bilirubin > 2.0 mg/dL, except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome; •\tTotal WBC count < 3,000/µL; •\tANC < 2,000/µL; •\tPlatelet count < 100,000/µL; •\tHemoglobin < 9.0 g/dL."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the achievement of HiSCR 75 at Week 16. HiSCR 75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline.","definition_or_measurement_approach":"HiSCR 75: at least a 75% reduction from baseline in total AN count, with no increase in abscess count and no increase in draining fistula count relative to baseline, assessed at Week 16."}

Secondary endpoints

• {"endpoint_text":"- Ranked Secondary Endpoints: Achievement of NRS30 (at least a 30% reduction and at least 2-units reduction from Baseline in the Patient's Global Assessment of HS-related skin pain NRS) at Week 8 among subjects with NRS ≥ 3 at Baseline. The NRS30 is based on worst skin pain in a 24-hour recall period (maximal daily pain); \"","definition_or_measurement_approach":"NRS30 = ≥30% reduction and ≥2-unit reduction from baseline on Patient's Global Assessment of HS-related skin pain (NRS) based on worst 24-hour recall; assessed at Week 8 in subjects with baseline NRS ≥3."}
• {"endpoint_text":"- Change from Baseline in DLQI at Week 16 among subjects ≥ 16 years of age at Baseline;","definition_or_measurement_approach":"Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16 for subjects aged ≥16 at baseline."}
• {"endpoint_text":"- Change from Baseline in HSIA at Week 16","definition_or_measurement_approach":"Change from baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) score at Week 16."}
• {"endpoint_text":"- Change from Baseline in HSSA Worst Drainage Score at Week 16;","definition_or_measurement_approach":"Change from baseline in HSSA (Hidradenitis Suppurativa Symptom Assessment) worst drainage score at Week 16."}
• {"endpoint_text":"- Change from Baseline in Draining Fistula at Week 16 among subjects with at least 1 draining fistula at Baseline;","definition_or_measurement_approach":"Change from baseline in number/score of draining fistulae at Week 16 among participants who had ≥1 draining fistula at baseline."}
• {"endpoint_text":"- Achievement of HiSCR 90 (at least a 90% reduction in the total AN count with no increase in abscess count and no increase in draining fistula count relative to Baseline) at Week 16;","definition_or_measurement_approach":"HiSCR 90 = ≥90% reduction in total AN count with no increase in abscess count and no increase in draining fistula count relative to baseline; assessed at Week 16."}
• {"endpoint_text":"- Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) at Week 8;","definition_or_measurement_approach":"Change from baseline on the Patient's Global Assessment NRS for HS-related skin pain at Week 8."}
• {"endpoint_text":"- Change from Baseline in HSSA at Week 16;","definition_or_measurement_approach":"Change from baseline in HSSA (Hidradenitis Suppurativa Symptom Assessment) at Week 16."}
• {"endpoint_text":"- Change from Baseline in HS-related odor (smell), based on HSSA Question 8, at Week 16;","definition_or_measurement_approach":"Change from baseline in HS-related odor (HSSA question 8) at Week 16."}
• {"endpoint_text":"- Occurrence of HS flare, defined as at least one occurrence of a ≥ 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline during the first 16 weeks (Period 1).","definition_or_measurement_approach":"HS flare = at least one occurrence of ≥25% increase in AN count AND absolute increase of ≥2 versus baseline during first 16 weeks (Period 1)."}
• {"endpoint_text":"- Change from Baseline in HSIA Emotional Domain at Week 16;","definition_or_measurement_approach":"Change from baseline in the emotional domain subscore of the HSIA at Week 16."}
• {"endpoint_text":"- Change from Baseline in HSIA Mobility Domain at Week 16.","definition_or_measurement_approach":"Change from baseline in the mobility domain subscore of the HSIA at Week 16."}

Methods

• Doctor to Patient Email — physician-directed email outreach materials (documented country-specific 'Doctor to Patient Email' documents in multiple MSCs).
• Recruitment Brochure — printed/digital brochures for potential participants (country-specific recruitment brochure documents).
• Digital Ad Visuals — digital advertising assets/visuals for online recruitment (documents titled 'Digital Ad Visuals' for several countries).
• K1 Recruitment arrangements (site-level recruitment procedures) — country-specific K1 recruitment & ICF procedures documents.
• Recruitment campaign support via third-party vendors (e.g., Clinical Trial Media Inc. listed with 'Recruitment campaign' duty).

Bulgaria

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

11-11-2024

Processing Time Days

20

Number Of Sites

6

Number Of Participants

30

Primary sponsor

Full Name

AbbVie Deutschland GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Cytel Inc.

Responsibilities

Data Monitoring Committee

Name

WCG Clinical Inc.

Responsibilities

Cardiovascular Adjudication Commitee; Recruitment support

Name

IQVIA Limited

Name

Medidata Solutions Inc.

Name

Veeva Systems Inc.

Third parties

• {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Cardiovascular Adjudication Commitee","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Recruitment support","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"","organisation_type":"Health care"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Recruitment campaign","organisation_type":"Non-Pharmaceutical company"}