Hidradenitis Suppurativa
Conditions
Brief summary
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
Interventions
DRUGPlacebo
Administered IV
DRUGLY3041658
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of HS for at least 6 months * Have HS lesions in at least 2 different anatomic areas * Have inadequate response or intolerance to a 28 day course of oral antibiotics * Have a total count of abscesses and inflammatory nodules greater than or equal to 4 * Agree to use a topical antiseptic daily * Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed
Exclusion criteria
* Have more than 20 draining fistulae * Have received any biologic medication (adalimumab, etc.) for the treatment of HS * Plan to use oral opioids for HS-related pain during the study * Uncontrolled depression or suicidal thoughts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | Week 16 | The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count | Baseline, Week 16 | Mean Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the Hidradenitis Suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions. |
| Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS) | Baseline, Week 16 | The Skin Pain - HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 11-point horizontal scale anchored at 0 and 10, with 0 representing no skin pain and 10 representing skin pain as bad as you can imagine. The recall period is 7 days. |
Countries
Australia, United States
Participant flow
Pre-assignment details
Participants were randomized in a 2:1 ratio to receive either 600 milligram (mg) LY3041658, or placebo in the double blind period (16 weeks).
Participants by arm
| Arm | Count |
|---|---|
| Placebo/600 mg LY3041658 Participants received placebo administered intravenously (IV) once every 2 weeks (Q2W) for 16 weeks in double blind period.
Participants who previously assigned to placebo in double blind period received 600 mg LY3041658 administered IV Q2W until the last dosing visit in open-label period. | 22 |
| 600 mg LY3041658 / 600 mg LY3041658 Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period. | 45 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Blind Treatment (Week 0 - 16) | Lack of Efficacy | 1 | 0 |
| Double Blind Treatment (Week 0 - 16) | Lost to Follow-up | 3 | 4 |
| Double Blind Treatment (Week 0 - 16) | Other, Protocol Deviation | 0 | 1 |
| Double Blind Treatment (Week 0 - 16) | Other, Relocation | 0 | 1 |
| Double Blind Treatment (Week 0 - 16) | Physician Decision | 1 | 0 |
| Double Blind Treatment (Week 0 - 16) | Randomized but Never Treated | 2 | 3 |
| Double Blind Treatment (Week 0 - 16) | Withdrawal by Subject | 3 | 1 |
| Open-label Extension (Week 16 - 36) | Lost to Follow-up | 1 | 0 |
| Open-label Extension (Week 16 - 36) | Physician Decision | 0 | 1 |
| Open-label Extension (Week 16 - 36) | Withdrawal by Subject | 3 | 8 |
| Post-treatment Follow-up (10 Weeks) | Lost to Follow-up | 0 | 1 |
| Post-treatment Follow-up (10 Weeks) | Physician Decision | 0 | 1 |
| Post-treatment Follow-up (10 Weeks) | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo/600 mg LY3041658 | 600 mg LY3041658 / 600 mg LY3041658 | Total |
|---|---|---|---|
| Age, Continuous | 36.10 years STANDARD_DEVIATION 12.68 | 37.10 years STANDARD_DEVIATION 12.38 | 36.80 years STANDARD_DEVIATION 12.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 35 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 30 Participants | 46 Participants |
| Region of Enrollment Australia | 2 participants | 5 participants | 7 participants |
| Region of Enrollment United States | 20 participants | 40 participants | 60 participants |
| Sex: Female, Male Female | 12 Participants | 35 Participants | 47 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 22 | 0 / 49 | 0 / 39 |
| other Total, other adverse events | 10 / 45 | 2 / 22 | 13 / 49 | 2 / 39 |
| serious Total, serious adverse events | 0 / 45 | 2 / 22 | 1 / 49 | 0 / 39 |
Outcome results
Primary
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.
Time frame: Week 16
Population: Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 31.8 percentage of participants |
| 600 mg LY3041658 | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 48.9 percentage of participants |
p-value: 0.18995% CI: [-7.3, 41.4]Regression, Logistic
Secondary
Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)
The Skin Pain - HS Numeric Rating Scale (NRS) is a patient-administered, single-question, 11-point horizontal scale anchored at 0 and 10, with 0 representing no skin pain and 10 representing skin pain as bad as you can imagine. The recall period is 7 days.
Time frame: Baseline, Week 16
Population: mITT Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS) | -1.83 units on a scale | Standard Error 0.614 |
| 600 mg LY3041658 | Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS) | -1.78 units on a scale | Standard Error 0.418 |
p-value: 0.94995% CI: [-1.44, 1.53]ANCOVA
Secondary
Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count
Mean Change from baseline in total AN count at Week 16 was reported. Abscess and inflammatory nodule were counted for the Hidradenitis Suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.
Time frame: Baseline, Week 16
Population: mITT Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count | -1.85 count of abscess and inflammatory nodule | Standard Error 1.636 |
| 600 mg LY3041658 | Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count | -6.52 count of abscess and inflammatory nodule | Standard Error 1.133 |
p-value: 0.02495% CI: [-8.69, -0.64]ANCOVA