Hidradenitis SuppurativaPhase 2NCT03852472

Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)

A Phase 2 study testing Avacopan in people with Hidradenitis Suppurativa and Acne Inversa, run by Amgen at 91 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hidradenitis Suppurativa, Acne Inversa
What is being tested?: Avacopan
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 435 participants
Where: 91 sitesUnited States
Study dates: 21 Dec 2018to 9 Mar 2021
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 18 years of age
Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
HS lesions are present in at least 2 distinct anatomic areas
Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
Must have at least 5 inflammatory nodules or abscesses at screening
Use adequate birth control for subject and partners of child bearing potential
Willing and able to give written Informed Consent

Who cannot join

Pregnant or breast-feeding
Any other skin disease that may interfere with the assessment of HS
Rapidly progressive, expanding HS within 30 days prior to screening
More than 20 draining fistulae at screening
Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment
Systemic antibiotics are generally excluded

Show all 10Show fewer

Topical antibiotics use within 14 days prior to Day 1 is excluded
Have started a topical prescription medicine for HS within 14 days prior to screening
A systemic medicine for HS, including biologics and other systemic therapies
Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason

Trial locations and contacts

91 sites in 1 country.

City, postcode or hospital

91 sites in 1 country

United States91 sites

Clinical Site
Athens, Ohio, 45701
Clinical Site
Atlanta, Georgia, 30322
Clinical Site
Austin, Texas, 78660
Clinical Site
Austin, Texas, 78745
Clinical Site
Beverly, Massachusetts, 01915
Clinical Site
Bexley, Ohio, 43209
Clinical Site
Birmingham, Alabama, 35233
Clinical Site
Birmingham, Alabama, 35244
Clinical Site
Boca Raton, Florida, 33486
Clinical Site
Boise, Idaho, 83713
Clinical Site
Boston, Massachusetts, 02101
Clinical Site
Chapel Hill, North Carolina, 27516
Clinical Site
Charleston, South Carolina, 29407
Clinical Site
Charlotte, North Carolina, 028277
Clinical Site
Charlotte, North Carolina, 28209
Clinical Site
Charlotte, North Carolina, 28277
Clinical Site
Clarkston, Michigan, 48346
Clinical Site
Clearwater, Florida, 33765
Clinical Site
Cleveland, Ohio, 44106
Clinical Site
Crown Point, Indiana, 46307
Clinical Site
Dallas, Texas, 75231
Clinical Site
Drexel Hill, Pennsylvania, 19026
Clinical Site
Evansville, Indiana, 47715
Clinical Site
Fort Gratiot, Michigan, 48059
Clinical Site
Fort Smith, Arkansas, 72916
Clinical Site
Fountain Valley, California, 92708
Clinical Site
Fremont, California, 94538
Clinical Site
Fullerton, California, 92821
Clinical Site
Hershey, Pennsylvania, 17033
Clinical Site
Hialeah, Florida, 33016
Clinical Site
Hollywood, Florida, 33021
Clinical Site
Homestead, Florida, 33030
Clinical Site
Houston, Texas, 77054
Clinical Site
Houston, Texas, 77056
Clinical Site
Houston, Texas, 77084
Clinical Site
Huntington Beach, California, 92647
Clinical Site
Indianapolis, Indiana, 46250
Clinical Site
Inglewood, California, 90301
Clinical Site
Largo, Maryland, 20774
Clinical Site
Los Angeles, California, 90025
Clinical Site
Los Angeles, California, 90045
Clinical Site
Los Angeles, California, 90057
Clinical Site
Louisville, Kentucky, 40217
Clinical Site
Manhattan Beach, California, 90266
Clinical Site
Marietta, Georgia, 30060
Clinical Site
Marion, Ohio, 43302
Clinical Site
Mason, Ohio, 45040
Clinical Site
Metairie, Louisiana, 70006
Clinical Site
Miami, Florida, 33125
Clinical Site
Miami, Florida, 33144
Clinical Site
Miami, Florida, 33173
Clinical Site
Minneapolis, Minnesota, 55455
Clinical Site
Mobile, Alabama, 36608
Clinical Site
Morgantown, West Virginia, 26505
Clinical Site
Nashville, Tennessee, 37215
Clinical Site
New Orleans, Louisiana, 70124
Clinical Site
New York, New York, 10012
Clinical Site
Newnan, Georgia, 30263
Clinical Site
Newport Beach, California, 92660
Clinical Site
Norman, Oklahoma, 73071
Clinical Site
Northridge, California, 91324
Clinical Site
Ocala, Florida, 34470
Clinical Site
Omaha, Nebraska, 68144
Clinical Site
Orlando, Florida, 32819
Clinical Site
Pembroke Pines, Florida, 33028
Clinical Site
Philadelphia, Pennsylvania, 19104
Clinical Site
Phoenix, Arizona, 85006
Clinical Site
Portland, Oregon, 97210
Clinical Site
Quincy, Massachusetts, 94598
Clinical Site
Redwood City, California, 94063
Clinical Site
Rochester, New York, 14623
Clinical Site
Rogers, Arkansas, 72758
Clinical Site
Saint Joseph, Michigan, 49085
Clinical Site
San Antonio, Texas, 78218
Clinical Site
Sandy Springs, Georgia, 30328
Clinical Site
Scottsdale, Arizona, 85255
Clinical Site
Skokie, Illinois, 60077
Clinical Site
Skokie, Illinois, 60640
Clinical Site
Spokane, Washington, 99202
Clinical Site
St Louis, Missouri, 63110
Clinical Site
Sugar Land, Texas, 77027
Clinical Site
Tampa, Florida, 33603
Clinical Site
Tampa, Florida, 33614
Clinical Site
Tampa, Florida, 33624
Clinical Site
Thousand Oaks, California, 91320
Clinical Site
Troy, Michigan, 48084
Clinical Site
Verona, New Jersey, 07044
Clinical Site
Walnut Creek, California, 94598
Clinical Site
Warwick, Rhode Island, 02886
Clinical Site
Weston, Florida, 33327
Clinical Site
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

Read the detailed description

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa.

The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks.

Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks.

Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Primary efficacy analysis will be at 12 weeks.

Conditions: Hidradenitis Suppurativa, Acne Inversa
Being tested: Avacopan, Placebo
Keywords: Avacopan, ChemoCentryx, Skin Disease, Inflammatory nodule, Abscess, Sinus formation, Fistula formation
Medical subject headings: Hidradenitis Suppurativa, Skin Diseases, Abscess

What participants receive

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

AvacopanDrug
Also called CCX168
Active treatment
PlaceboOther
Placebo

Study groups in NCT03852472
Study group	Role	What they receive
Group A	Placebo comparator	Placebo twice daily (BID) for Period 1 of the study Receives: Other: Placebo
Group B	Experimental	Avacopan 10 mg twice daily (BID) for Period 1+2 of the study Receives: Drug: Avacopan
Group C	Experimental	Avacopan 30 mg twice daily (BID) for Period 1+2 of the study Receives: Drug: Avacopan
Placebo to Avacopan 10 mg	Experimental	Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2. Receives: Drug: Avacopan
Placebo to Avacopan 30 mg	Experimental	Treatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2. Receives: Drug: Avacopan

What is being measured

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

Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.
Measured: Baseline to Week 12

Secondary outcomes (9)

Change From Baseline in Total AN Count at Week 12
The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
MMRM - mixed effects model for repeated measures; OC- observed case
Measured: Baseline to Week 12
Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12
NRS30 = The number of responders achieving at least 30% reduction and at least 1 unit reduction from baseline in the subject's global assessment of skin pain score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group.
Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
NRI- non-responder imputation
Measured: Baseline to Week 12
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population.
PK- pharmacokinetics
Measured: Day 1
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Measured: Baseline and Week 12
Change of IHS4 Score Relative to Baseline at Week 12.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + [number of draining tunnels (fistulae/sinuses) multiplied by 4]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS.
IHS4- International HS Severity Scoring System
Measured: Baseline and Week 12
Change From Baseline in Inflammatory Nodule Count at Week 12
A reduction in AN signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Measured: Baseline and Week 12
Change From Baseline in Abscess Count at Week 12
A reduction in abscess count signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Measured: Baseline and Week 12
Change From Baseline in Draining Fistula Count at Week 12
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Measured: Baseline and Week 2, Week 4, Week 8 and Week 12
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Measured: Baseline and Week 2, Week 4, Week 8 and Week 12

Timeline

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

21 Dec 20189 Mar 2021

First posted25 Feb 2019
Study start21 Dec 2018
Primary completion14 Jan 2021
Study completion9 Mar 2021

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 AmgenThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 435 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03852472
Sponsor's protocol ID: CL016_168
Status last verified: Feb 2025
First submitted: 22 Feb 2019
Last updated: 17 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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
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All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized , Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT03852472
Acronym / sponsor ID: CL016_168
Conditions: Hidradenitis Suppurativa, Acne Inversa
Keywords: Avacopan, ChemoCentryx, Skin Disease, Inflammatory nodule, Abscess, Sinus formation, Fistula formation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 435 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 21 Dec 2018 (actual)
Primary completion: 14 Jan 2021 (actual)
Study completion: 9 Mar 2021 (actual)
First posted: 25 Feb 2019 (actual)
Results: Posted 15 Mar 2024

Clinical summary

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

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

Detailed description

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa.

Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Primary efficacy analysis will be at 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group A	Placebo comparator	Other: PlaceboPlacebo twice daily (BID) for Period 1 of the study
Group B	Experimental	Drug: AvacopanAvacopan 10 mg twice daily (BID) for Period 1+2 of the study
Group C	Experimental	Drug: AvacopanAvacopan 30 mg twice daily (BID) for Period 1+2 of the study
Placebo to Avacopan 10 mg	Experimental	Drug: AvacopanTreatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.
Placebo to Avacopan 30 mg	Experimental	Drug: AvacopanTreatment period 2, subjects randomized to placebo during period 1 were rerandomized 1:1 to receive 10 mg or 30 mg avacopan BID in period 2.

Who may qualify

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

Key inclusion criteria (7 listed)

At least 18 years of age
Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
HS lesions are present in at least 2 distinct anatomic areas
Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
Must have at least 5 inflammatory nodules or abscesses at screening

Key exclusion criteria (10 listed)

Pregnant or breast-feeding
Any other skin disease that may interfere with the assessment of HS
Rapidly progressive, expanding HS within 30 days prior to screening
More than 20 draining fistulae at screening
Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment >12 weeks prior to Day 1 visit are allowed for enrollment

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
AvacopanAlso: CCX168Active treatment	Drug	Group B, Group C, Placebo to Avacopan 10 mg, Placebo to Avacopan 30 mg
PlaceboPlacebo	Other	Group A

Primary outcome

Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
Time frame: Baseline to Week 12
The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.

9 secondary outcomes

Change From Baseline in Total AN Count at Week 12
Time frame: Baseline to Week 12
Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12
Time frame: Baseline to Week 12
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
Time frame: Day 1
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
Time frame: Baseline and Week 12
Change of IHS4 Score Relative to Baseline at Week 12.
Time frame: Baseline and Week 12
Change From Baseline in Inflammatory Nodule Count at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Abscess Count at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Draining Fistula Count at Week 12
Time frame: Baseline and Week 2, Week 4, Week 8 and Week 12
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Time frame: Baseline and Week 2, Week 4, Week 8 and Week 12

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	130	109
Group B	134	108
Group C	134	109
Placebo to Avacopan 10 mg	0	0
Placebo to Avacopan 30 mg	0	0

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

Time frame: Baseline to Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 130	Avacopan 10 mg n = 134	Avacopan 30 mg n = 134
Value	30.8	22.4	35.1

Placebo vs Avacopan 10 mg: % Difference (Avacopan - Placebo): -8.4 (95% CI -18.7 to 2.4), p = 0.1321, Cochran-Mantel-Haenszel
Placebo vs Avacopan 30 mg: % Difference (Avacopan - Placebo): 4.3 (95% CI -6.9 to 15.5), p = 0.4503, Cochran-Mantel-Haenszel

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All subjects in Period 1 +2 of the study through completion of study an average of 44 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Period 1	3 of 129 (2.3%)	22 of 129 (17.1%)	0 of 129
Avacopan 10 mg Period 1	3 of 134 (2.2%)	18 of 134 (13.4%)	0 of 134
Avacopan 30 mg Period 1	1 of 135 (0.7%)	15 of 135 (11.1%)	0 of 135
Placebo to Avacopan 10 mg Period 2	0 of 56 (0%)	7 of 56 (12.5%)	0 of 56
Placebo to Avacopan 30 mg Period 2	1 of 52 (1.9%)	8 of 52 (15.4%)	0 of 52
Avacopan 10 mg Period 2	4 of 108 (3.7%)	21 of 108 (19.4%)	0 of 108
Avacopan 30 mg Period 2	2 of 109 (1.8%)	20 of 109 (18.3%)	0 of 109

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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
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Active, not recruiting
Acceptability of MBSR for People With HS
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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.

MD study director

Amgen

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avacopan in people with Hidradenitis Suppurativa and Acne Inversa, run by Amgen at 91 sites in United States.

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 7 inclusion and 10 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Mar 2024). 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 Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. (time frame: Baseline 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 NCT03852472.

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 17 Mar 2025.