Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

NCT02904902 | Completed Phase 3 Results

• 1 other identifier: M15-573
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief Summary

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

Conditions

Hidradenitis Suppurativa

Keywords

efficacy; safety; adalimumab; japanese participants

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

  HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

  Week 12

Secondary Outcomes (3)

• Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12

  Week 12

• Percentage of Participants Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 2 Among Participants With Baseline Numeric Rating Scale (NRS) >=3

  Week 0 (Baseline), Week 2

• Change From Baseline to Week 12 in Modified Sartorius Scale Score

  Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12

Study Arms (1)

Adalimumab

EXPERIMENTAL

Open-label adalimumab 160 mg subcutaneous injection at Week 0 (Baseline), 80 mg at Week 2, and 40 mg every week starting at Week 4. After Week 52, Participants who consent to receive the 80 mg eow dose, will switch from 40 mg ew to 80 mg eow at Week 0x (80 mg eow period until the end of the study).

Drug: adalimumab

Interventions

adalimumab DRUG

Subcutaneous Injection

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have a diagnosis of HS;
• Participant must have any HS symptom at least 6 months prior to Baseline;
• HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;
• Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;
• Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.

You may not qualify if:

• Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;
• Any other active skin lesion or condition that may interfere with assessment of HS;
• Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
• Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;
• Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;
• Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (8)

Nagoya City University Hospital /ID# 151495

Nagoya, Aichi-ken, 467-8602, Japan

Location

Kurume University Hospital /ID# 152579

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Takagi Dermatological Clinic /ID# 151906

Obihiro, Hokkaido, 080-0013, Japan

Location

University of the Ryukyus Hosp /ID# 152268

Nakagami-gun, Okinawa, 903-0215, Japan

Location

NHO Osaka National Hosp /ID# 152452

Osaka, Osaka, 540-0006, Japan

Location

Tokai University Hachioji Hosp /ID# 151338

Hachiōji, Tokyo, 〒192-0032, Japan

Location

Tokyo Medical University Hospital /ID# 154171

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Fukuoka University Hospital /ID# 151350

Fukuoka, 814-0180, Japan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: September 6, 2016
• Primary Completion: September 1, 2017
• Study Completion: May 30, 2019
• Last Updated: May 12, 2020
• Results First Posted: February 27, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

JP (8)