Trial Outcomes & Findings for A Study of LY3041658 in Adults With Hidradenitis Suppurativa (NCT NCT04493502)
NCT ID: NCT04493502
Last Updated: 2023-04-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Week 16
Results posted on
2023-04-28
Participant Flow
Participants were randomized in a 2:1 ratio to receive either 600 milligram (mg) LY3041658, or placebo in the double blind period (16 weeks).
Participant milestones
| Measure |
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.
Follow-up Period: Participants did not receive study drug during this period.
|
600 mg LY3041658 / 600 mg LY3041658
Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period.
Follow-up Period: Participants did not receive study drug during this period.
|
|---|---|---|
|
Double Blind Treatment (Week 0 - 16)
STARTED
|
24
|
48
|
|
Double Blind Treatment (Week 0 - 16)
Received at Least One Dose of Study Drug
|
22
|
45
|
|
Double Blind Treatment (Week 0 - 16)
COMPLETED
|
14
|
38
|
|
Double Blind Treatment (Week 0 - 16)
NOT COMPLETED
|
10
|
10
|
|
Open-label Extension (Week 16 - 36)
STARTED
|
14
|
38
|
|
Open-label Extension (Week 16 - 36)
Received at Least One Dose of Study Drug
|
13
|
36
|
|
Open-label Extension (Week 16 - 36)
COMPLETED
|
10
|
29
|
|
Open-label Extension (Week 16 - 36)
NOT COMPLETED
|
4
|
9
|
|
Post-treatment Follow-up (10 Weeks)
STARTED
|
10
|
29
|
|
Post-treatment Follow-up (10 Weeks)
COMPLETED
|
8
|
24
|
|
Post-treatment Follow-up (10 Weeks)
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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.
Follow-up Period: Participants did not receive study drug during this period.
|
600 mg LY3041658 / 600 mg LY3041658
Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period.
Follow-up Period: Participants did not receive study drug during this period.
|
|---|---|---|
|
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, Relocation
|
0
|
1
|
|
Double Blind Treatment (Week 0 - 16)
Other, Protocol Deviation
|
0
|
1
|
|
Double Blind Treatment (Week 0 - 16)
Physician Decision
|
1
|
0
|
|
Double Blind Treatment (Week 0 - 16)
Withdrawal by Subject
|
3
|
1
|
|
Double Blind Treatment (Week 0 - 16)
Randomized but Never Treated
|
2
|
3
|
|
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
A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Placebo/600 mg LY3041658
n=22 Participants
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.
|
600 mg LY3041658 / 600 mg LY3041658
n=45 Participants
Participants received 600 mg LY3041658 administered IV Q2W in double blind and open-label period.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.10 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
37.10 years
STANDARD_DEVIATION 12.38 • n=7 Participants
|
36.80 years
STANDARD_DEVIATION 12.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
40 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Modified Intent-to-Treat (mITT) Population: All randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received placebo administered IV Q2W for 16 weeks.
|
600 mg LY3041658
n=45 Participants
Participants received 600 mg LY3041658 administered IV Q2W for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
|
31.8 percentage of participants
Interval 12.4 to 51.3
|
48.9 percentage of participants
Interval 34.3 to 63.5
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT Population: All randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received placebo administered IV Q2W for 16 weeks.
|
600 mg LY3041658
n=45 Participants
Participants received 600 mg LY3041658 administered IV Q2W for 16 weeks.
|
|---|---|---|
|
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
|
-6.52 count of abscess and inflammatory nodule
Standard Error 1.133
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: mITT Population: All randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Placebo
n=22 Participants
Participants received placebo administered IV Q2W for 16 weeks.
|
600 mg LY3041658
n=45 Participants
Participants received 600 mg LY3041658 administered IV Q2W for 16 weeks.
|
|---|---|---|
|
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
|
-1.78 units on a scale
Standard Error 0.418
|
Adverse Events
600 mg LY3041658 _Double-Blind Treatment Period
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo_Double-Blind Treatment Period
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
600 mg LY3041658_Open-Label Extension
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Follow-Up Period
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
600 mg LY3041658 _Double-Blind Treatment Period
n=45 participants at risk
Participants received 600 mg LY3041658 IV Q2W for 16 weeks.
|
Placebo_Double-Blind Treatment Period
n=22 participants at risk
Participants received placebo IV Q2W for 16 weeks.
|
600 mg LY3041658_Open-Label Extension
n=49 participants at risk
Participants received 600 mg IV LY3041658 Q2W from week 16-34 weeks.
|
Follow-Up Period
n=39 participants at risk
Participants did not receive study drug during this period.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.0%
1/49 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
600 mg LY3041658 _Double-Blind Treatment Period
n=45 participants at risk
Participants received 600 mg LY3041658 IV Q2W for 16 weeks.
|
Placebo_Double-Blind Treatment Period
n=22 participants at risk
Participants received placebo IV Q2W for 16 weeks.
|
600 mg LY3041658_Open-Label Extension
n=49 participants at risk
Participants received 600 mg IV LY3041658 Q2W from week 16-34 weeks.
|
Follow-Up Period
n=39 participants at risk
Participants did not receive study drug during this period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.7%
3/45 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
3/45 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
General disorders
Fatigue
|
6.7%
3/45 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/49 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Covid-19
|
4.4%
2/45 • Number of events 2 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.5%
1/22 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.2%
5/49 • Number of events 5 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.6%
1/39 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
8.2%
4/49 • Number of events 4 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/45 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.1%
3/49 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
3/45 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.1%
2/49 • Number of events 3 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/39 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
10.0%
1/10 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/10 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Surgical and medical procedures
Scrotal operation
|
0.00%
0/10 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
10.0%
1/10 • Number of events 1 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/12 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/11 • Baseline Up to Follow-up Period (46 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60