Hidradenitis Suppurativa (HS)Phase 3PIONEER IINCT01468233

Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa

A Phase 3 study testing adalimumab in people with Hidradenitis Suppurativa (HS), run by AbbVie (prior sponsor, Abbott).

Completed

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

Trial summary

A study to evaluate the safety and efficacy of treatment with adalimumab in adults 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 (HS)
What is being tested?: adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: No sites listed yet
Study dates: Nov 2011to Apr 2014
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

Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
Subject must have a total AN count of greater than or equal to 3 at baseline.

Who cannot join

Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.
Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
If entering the study on concomitant oral analgesics for non-HS related pain:
Subject on opioid analgesics within 14 days prior to Baseline visit;
Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit ("as needed" is not considered a stable dose).

About this study

Official title: A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

Read the detailed description

The clinical trial identifier is PIONEER II. The purpose of this study is to evaluate the safety of adalimumab and to determine how well it works in the treatment of adults with moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps can heal themselves quickly and sometimes they will become much worse and create sores that heal with multiple combined scars, or areas that do not heal. In this study, approximately 300 adults will be enrolled at treatment centers worldwide. Subject participation in this study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30 days, and a study treatment period of up to 36 weeks. Study visits occur at Screening, Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves the study before Week 36). The study is divided into two treatment periods. The first period (Period A) will last 12 weeks and the second period (Period B) will last 24 weeks.

Conditions: Hidradenitis Suppurativa (HS)
Being tested: adalimumab, placebo
Keywords: placebo controlled, double blind, adalimumab, TNF, psoriasis, HS, PIONEER II, hidradenitis suppurativa, acne inversa, boil, acne
Medical subject headings: Hidradenitis Suppurativa, Psoriasis, Furunculosis, Acne Vulgaris

What participants receive

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

adalimumabBiological
Also called Humira
Adalimumab pre-filled syringe, administered by subcutaneous injection
placeboBiological
Placebo pre-filled syringe, administered by subcutaneous injection

Study groups in NCT01468233
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo for 12 weeks. Receives: Biological: placebo
Adalimumab Every Week (EW)	Experimental	Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12). Receives: Biological: adalimumab
Placebo/Placebo	Placebo comparator	Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks). Receives: Biological: placebo
Adalimumab Every Week (EW)/Placebo	Experimental	Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). Receives: Biological: adalimumab; Biological: placebo
Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)	Experimental	Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks). Receives: Biological: adalimumab
Adalimumab Every Week (EW)/Adalimumab Every Week (EW)	Experimental	Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks). Receives: Biological: 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 was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.
Measured: Baseline (Week 0) up to Week 12

Secondary outcomes (3)

Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (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 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.
Measured: Baseline (Week 0) up to 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 12 Among Participants With Baseline Skin Pain NRS ≥ 3
The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the 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." The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders.
Measured: Baseline (Week 0) up to Week 12
Change From Baseline to Week 12 in Modified Sartorius 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): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.
Measured: Baseline (Week 0) and Week 12

Timeline

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

Nov 2011Apr 2014

First posted9 Nov 2011 (estimated)
Study startNov 2011
Primary completionApr 2014
Study completionApr 2014

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01468233
Sponsor's protocol ID: M11-810
Other IDs: 2011-003406-24
Acronym: PIONEER II
Status last verified: Jul 2021
First submitted: 7 Nov 2011
Last updated: 12 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.
PubMed 27518661
Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.
PubMed 39141589
Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
PubMed 29380251

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?

Official record

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
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)
Not yet recruitingObservational study
A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
Hidradenitis Suppurativa

All Hidradenitis Suppurativa (HS) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II
ClinicalTrials.gov ID: NCT01468233
Acronym / sponsor ID: PIONEER II / M11-810
Conditions: Hidradenitis Suppurativa (HS)
Keywords: placebo controlled, double blind, adalimumab, TNF, psoriasis, HS, PIONEER II, hidradenitis suppurativa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 9 Nov 2011 (estimated)
Results: Posted 28 Oct 2015

Clinical summary

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

A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Biological: placeboPlacebo for 12 weeks.
Adalimumab Every Week (EW)	Experimental	Biological: adalimumabAdalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
Placebo/Placebo	Placebo comparator	Biological: placeboParticipants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Adalimumab Every Week (EW)/Placebo	Experimental	Biological: adalimumab, Biological: placeboParticipants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)	Experimental	Biological: adalimumabParticipants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
Adalimumab Every Week (EW)/Adalimumab Every Week (EW)	Experimental	Biological: adalimumabParticipants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).

Who may qualify

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

Key inclusion criteria (5 listed)

Adults must have a diagnosis of HS for at least 1 year prior to Baseline.
HS lesions must be present in at least two distinct anatomical areas, one of which must be at least Hurley Stage II or Hurley Stage III.
Subject must have stable HS for at least 60 days prior to Screening visit and at Baseline visit.
Subject must have experienced an inadequate response to at least a 90-day treatment of oral antibiotics for treatment of HS.
Subject must have a total AN count of greater than or equal to 3 at baseline.

Key exclusion criteria (6 listed)

Subject was previously treated with adalimumab or another anti-tumor necrosis factor (anti-TNF) therapy (e.g., infliximab or etanercept).
Subjects on permitted oral antibiotic treatment for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit.
Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to Baseline visit.
If entering the study on concomitant oral analgesics for non-HS related pain:

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: HumiraAdalimumab pre-filled syringe, administered by subcutaneous injection	Biological	Adalimumab Every Week (EW), Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW), Adalimumab Every Week (EW)/Adalimumab Every Week (EW), Adalimumab Every Week (EW)/Placebo
placeboPlacebo pre-filled syringe, administered by subcutaneous injection	Biological	Adalimumab Every Week (EW)/Placebo, Placebo, Placebo/Placebo

Primary outcome

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Time frame: Baseline (Week 0) up to Week 12
HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.

3 secondary outcomes

Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12
Time frame: Baseline (Week 0) up to 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 12 Among Participants With Baseline Skin Pain NRS ≥ 3
Time frame: Baseline (Week 0) up to Week 12
Change From Baseline to Week 12 in Modified Sartorius Score
Time frame: Baseline (Week 0) and Week 12

Results and safety

Results posted to the registry on 28 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	163	151
Adalimumab Every Week (EW)	163	155
Placebo/Placebo	0	0
Adalimumab Every Week (EW)/Placebo	0	0
Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)	0	0
Adalimumab Every Week (EW)/Adalimumab Every Week (EW)	0	0

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

Time frame: Baseline (Week 0) up to Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 163	Adalimumab Every Week (EW) n = 163	Placebo - Baseline Hurley Stage II n = 87	Placebo - Baseline Hurley Stage III n = 76	Adalimumab Every Week (EW) - Baseline Hurley Stage II n = 85	Adalimumab Every Week (EW) - Baseline Hurley Stage III n = 78
Value	27.6	58.9	36.8	17.1	62.4	55.1

Placebo vs Adalimumab Every Week (EW): Adjusted mean difference: 31.5 (95% CI 20.7 to 42.2), p <0.001, Cochran-Mantel-Haenszel
Placebo - Baseline Hurley Stage II vs Adalimumab Every Week (EW) - Baseline Hurley Stage II: Adjusted mean difference: 25.5 (95% CI 10.5 to 40.5), p <0.001, Cochran-Mantel-Haenszel
Placebo - Baseline Hurley Stage III vs Adalimumab Every Week (EW) - Baseline Hurley Stage III: Adjusted mean difference: 38.1 (95% CI 22.8 to 53.3), p <0.001, Cochran-Mantel-Haenszel

Population analysed: The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from first dose of study drug until 70 days following last dose of study drug (46 weeks); Serious Adverse Events were collected from the time that informed consent was obtained (up to 50 weeks).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Period 1)	6 of 163 (3.7%)	77 of 163 (47.2%)	Not reported
Adalimumab EW (Period 1)	3 of 163 (1.8%)	66 of 163 (40.5%)	Not reported
Placebo/Placebo (Period 2)	7 of 151 (4.6%)	48 of 151 (31.8%)	Not reported
Adalimumab EW/Placebo (Period 2)	0 of 51 (0%)	27 of 51 (52.9%)	Not reported
Adalimumab EW/Adalimumab EOW (Period 2)	2 of 53 (3.8%)	25 of 53 (47.2%)	Not reported
Adalimumab EW/Adalimumab EW (Period 2)	2 of 51 (3.9%)	21 of 51 (41.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27518661Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.
Derived from this study: PubMed 39141589Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.
Derived from this study: PubMed 29380251Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Related InfoLink provided by the sponsor.

Related trials for Hidradenitis Suppurativa (HS)

Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
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Acceptability of MBSR for People With HS
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A Study of Early Secukinumab Treatment in Moderate to Severe Hidradenitis Suppurativa Patients
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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.

Martin Okun, MD study chair

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adalimumab in people with Hidradenitis Suppurativa (HS), run by AbbVie (prior sponsor, Abbott).

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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 28 Oct 2015). 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: Baseline (Week 0) up to 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 NCT01468233, which also lists 3 linked publications.

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 Jul 2021.