Health TrialsbyHealthPanel

A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum

ConditionPyoderma Gangrenosum
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLEO Pharma

About this trial

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size.

This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.

In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.

In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.

Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.

Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.

At least one measurable (defined as measuring ≥5 cm²) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.

Disqualifiers

Trial participants with non-PG lesions.

Trial participants with a target PG ulcer measuring >80 cm².

Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.

Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spesolimab

    Drug

    Solution for infusion

  • Placebo matching to spesolimab

    Drug

    Placebo matching to spesolimab

  • Prednisone

    Drug

    Prednisone

  • Prednisolone

    Drug

    Prednisolone

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: SpesolimabExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.

Time frame
Up to Week 28.

Secondary outcomes

1

Key secondary endpoint: Achievement of PGAR-100 of the target PG ulcer at Week 26 confirmed at the next consecutive visit (at least 2 weeks later)

PGAR-100 is defined as complete closure and re-epithelisation of a PG ulcer without drainage and requirements for dressing.

Time frame
Up to Week 28.
2

Achievement of 50% area reduction (PGAR-50) of the target PG ulcer at any time up to Week 26

Achievement of a PGAR-50 defines an area reduction of a PG ulcer from baseline by 50%.

Time frame
Up to Week 26.
3

Achievement of ≥ 3 point reduction in NRS Pain score from baseline at Week 26

Numeric Rating Scale for Pain (NRS Pain) is a unidimensional measure of pain intensity. It is a 11-point numeric scale, in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing "worst pain imaginable". Trial participant is asked to report their pain intensity in the last 24 h.

Time frame
At baseline and at Week 26.
4

Achievement of a DLQI of ≤ 5 at Week 26

Dermatology Life Quality Index (DLQI) is a trial participant-administered, quality of life questionnaire consisting of 10 questions that cover 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, problems with treatment). Response categories include "not relevant" or "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question, resulting in a range of 0 to 30, with higher scores indicating more impairment of a trial participant's quality of life.

Time frame
At Week 26.

Other outcomes

Sponsors and contacts

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

LEO Pharma

Lead sponsor

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov
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