A global study comparing ABBV-066 to placebo in adult subjects with Hidradenitis Suppurativa

Phase 1

• Conditions: Hidradenitis Suppurativa; MedDRA version: 20.0Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-000122-21-NL
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Subjects must be = 18 years old at Screening with a clinical diagnosis of moderate to severe HS (defined as a total AN count of = 5 at Baseline, presence of HS lesions in at least 2 distinct anatomic areas, and draining fistula count of = 20 at Baseline) for at least 1 year prior to Baseline, as determined by the investigator (i.e., through medical history, interview of subject).
• Subjects must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.
• Prior exposure to anti-IL12/23/17 (overall, no more than 10% of the study population)
• Prior exposure to anti-TNF (overall, no more than 15% of the study population)
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

No history of active skin disease other than HS that could interfere with the assessment of HS.
No active TB or concurrent treatment for latent TB and no evidence of HBV, HCV or HIV.
No documented active or suspected malignancy or history of any malignancy within the last 5 years.
No history of organ transplantation.
No exposure to other immunomodulatory biologic therapies, including anti-IL-1 within 3 months or 5 half-lives, whichever is longer, prior to Baseline.
No previous treatment with any cell-depleting therapies including but not limited to anti-CD20 within 12 months prior to Baseline or until B cell count returns to normal level.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified