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Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity

ConditionHidradenitis Suppurativa
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study will test an experimental Regeneron drug called olatorepatide ("study drug") to see if it can help treat Hidradenitis Suppurativa (HS).

In this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.

The study is looking at:

* What side effects olatorepatide might cause * How well olatorepatide works * How much olatorepatide is in the blood at different times * If the body makes antibodies to olatorepatide, which may cause olatorepatide to not work as well

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented or reported history of HS for ≥6 months prior to baseline visit

Confirmation of HS by the investigator during physical examination at screening

HS lesions present in at least 2 distinct anatomic areas as described in the protocol

Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)

Disqualifiers

Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial

Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol

Current heart failure classified as being in NYHA Class IV at screening

History of chronic pancreatitis or acute pancreatitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olatorepatide

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: OlatorepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in total Abscess and inflammatory Nodule (AN) count

Time frame
From baseline to week 52

Secondary outcomes

1

Percent change in body weight

Time frame
From baseline to week 52
2

Achieving HiSCR50 (≥50% reduction from baseline in total AN counts with no increase in abscess count and no increase in draining tunnel count)

Time frame
At week 52
3

Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)

Time frame
From baseline to week 52
4

Percent change in weekly average Skin Pain NRS

Time frame
From baseline to week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: