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

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ClinicalTrials.gov Identifier: NCT02904902
Recruitment Status : Active, not recruiting
First Posted : September 19, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe Hidradenitis Suppurativa (HS).

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Drug: Adalimumab Phase 3

Detailed Description:
Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were completed in the Western countries and market authorization of adalimumab was approved in US and European Union (EU) for the treatment of subjects with HS. The differences between this study and global studies include sample size, study design, duration, and race.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : September 1, 2017
Estimated Study Completion Date : May 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Patients receiving adalimumab
Subcutaneous injection of dose A at Week 0 (Baseline) and dose B at Week 2 followed by weekly dosing of dose C from Week 4
Drug: Adalimumab
Sub-cutaneous Injection
Other Name: Humira




Primary Outcome Measures :
  1. Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 [ Time Frame: At Week 12 ]
    HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining fistula count relative to Baseline.


Secondary Outcome Measures :
  1. Proportion of participants achieving AN count of 0, 1, or 2 at Week 12 [ Time Frame: At Week 12 ]
    The proportion of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with AN counts >=3 at Baseline

  2. Proportion 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 NRS >=3 [ Time Frame: Week 0 (baseline) up to Week 12 ]
    The patient's Global Assessment of Skin Pain Numeric Rating Scale was used to assess the worst skin and average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the "last 24 hours".

  3. Change in modified Sartorius scale [ Time Frame: Week 0 (baseline) and Week 12 ]
    The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodule (2 points for each); abscesses (4 points); fistulas (4 points); scar (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points) The total Sartorius Scale is the sum of the 12 regional scores. Scale range will be 0 to infinite and larger scale represents higher severity of HS.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must have a diagnosis of hidradenitis suppurativa (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 AN count of greater than or equal to 3 at the Baseline visit.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904902


Locations
Japan
Nagoya City University Hospital /ID# 151495
Nagoya-shi, Aichi, Japan, 467-8602
Kurume University Hospital /ID# 152579
Kurume-shi, Fukuoka, Japan, 830-0011
Takagi Dermatological Clinic /ID# 151906
Obihiro, Hokkaido, Japan, 080-0013
University of the Ryukyus Hosp /ID# 152268
Nakagami-gun, Okinawa, Japan, 903-0215
NHO Osaka National Hosp /ID# 152452
Osaka-shi, Osaka, Japan, 540-0006
Tokai University Hachioji Hosp /ID# 151338
Hachioji, Tokyo, Japan, 〒192-0032
Tokyo Medical University Hospital /ID# 154171
Shinjuku-ku, Tokyo, Japan, 160-0023
Fukuoka University Hospital /ID# 151350
Fukuoka, Japan, 814-0180
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
AbbVie  This link exits the ClinicalTrials.gov site

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02904902     History of Changes
Other Study ID Numbers: M15-573
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
efficacy
safety
adalimumab
japanese participants

Additional relevant MeSH terms:
Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents