Hidradenitis SuppurativaPhase 3NCT02904902

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

A Phase 3 study testing adalimumab in people with Hidradenitis Suppurativa, run by AbbVie at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hidradenitis Suppurativa
What is being tested?: adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 8 sitesJapan
Study dates: 6 Sep 2016to 30 May 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 sites

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

Other trials in Japan

About this study

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

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

Read the 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 United States (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.

Conditions: Hidradenitis Suppurativa
Being tested: adalimumab
Keywords: efficacy, safety, adalimumab, japanese participants
Medical subject headings: Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

adalimumabDrug
Also called Humira
Subcutaneous Injection

Study groups in NCT02904902
Study group	Role	What they receive
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). Receives: Drug: adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12

Secondary outcomes (3)

Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.
Measured: 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
The participant's Global Assessment of Skin Pain NRS was used to assess the worst skin pain due to HS. Scores 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."
Measured: Week 0 (Baseline), Week 2
Change From Baseline to Week 12 in Modified Sartorius Scale Score
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). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); 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 score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.
Measured: Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201630 May 2019

First posted19 Sep 2016 (estimated)
Study start6 Sep 2016
Primary completion1 Sep 2017
Study completion30 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02904902
Sponsor's protocol ID: M15-573
Status last verified: Apr 2020
First submitted: 14 Sep 2016
Last updated: 12 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02904902
Acronym / sponsor ID: M15-573
Conditions: Hidradenitis Suppurativa
Keywords: efficacy, safety, adalimumab, japanese participants
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 6 Sep 2016 (actual)
Primary completion: 1 Sep 2017 (actual)
Study completion: 30 May 2019 (actual)
First posted: 19 Sep 2016 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Adalimumab	Experimental	Drug: adalimumabOpen-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).

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
adalimumabAlso: HumiraSubcutaneous Injection	Drug	Adalimumab

Primary outcome

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Time frame: 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.

3 secondary outcomes

Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12
Time frame: 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
Time frame: Week 0 (Baseline), Week 2
Change From Baseline to Week 12 in Modified Sartorius Scale Score
Time frame: Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	15	14

Primary outcome: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Adalimumab n = 15
Value	86.7 (59.5 to 98.3)

Population analysed: Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Non responder imputation.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through 70 days after the last dose of study drug. The mean duration of adalimumab exposure was 717.5 days (median 742.0 days, range 112 - 883 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	5 of 15 (33.3%)	15 of 15 (100%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
clinical study report synopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Hidradenitis Suppurativa

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AbbVie Inc. study director

AbbVie

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Hidradenitis Suppurativa, run by AbbVie at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02904902.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.