A Study of LY3041658 in Adults With Hidradenitis Suppurativa

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Lilly

Status and phase

Completed
Phase 2

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Placebo
Drug: LY3041658

Study type

Interventional

Funder types

Industry

Identifiers

NCT04493502
I7P-MC-DSAD (Other Identifier)
17497

Details and patient eligibility

About

The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups, including a placebo group

LY3041658
Experimental group
Description:
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
Treatment:
Drug: LY3041658
Placebo
Placebo Comparator group
Description:
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
Treatment:
Drug: LY3041658
Drug: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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