A study to test long-term treatment with Spesolimab in people with Palmoplantar Pustulosis (PPP) who took part in previous studies with Spesolimab

Phase 1

Conditions: Palmoplantar Pustulosis
MedDRA version: 21.1Level: PTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2020-000189-41-CZ

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 140

Inclusion Criteria

- Signed and dated written informed consent for the current trial 1368-0024, in accordance
with ICH-GCP and local legislation prior to admission to the current trial
- Male or female patients who have completed the treatment period in one of the parent
trials without premature discontinuation
- Patients who have obtained an individual health benefit, per investigator judgement (e.g.
PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment
in the parent trial.
- Women of childbearing potential must be ready and able to use highly effective methods
of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly. A list of contraception methods meeting these
criteria is provided in Section 4.2.3 and in the patient information. Note: A woman is
considered of childbearing potential, i.e. fertile, following menarche and until becoming
postmenopausal unless permanently sterile. Permanent sterilisation methods include
hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not
a method of permanent sterilization. A postmenopausal state is defined as no menses for
12 months without an alternative medical cause.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- Patients who experienced study treatment-limiting adverse events during the parent trial.
- Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Patients with congestive heart disease, as assessed by the investigator.
- Patient with a transplanted organ (with exception of a corneal transplant >12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal).
- Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly).
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening in parent trial, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
- Patients who have developed active or severe infective disease and opportunistic infections/infective diseases.
-- Patients with latent TB during preceding trial are allowed to be included in study 1368-0024, provided they have received and/or receive currently appropriate treatment according to local guidelines.
- Further criteria apply

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and efficacy of Spesolimab (BI 655130) in patients with PPP, who have completed previous Spesolimab (BI 655130) trials and are qualified for entry in this trial.;Secondary Objective: Supportive efficacy assessments will also be done on pre-specified secondary endpoints.;Primary end point(s): 1) occurrence of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: 1) up to 260 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Percent change in PPP ASI from baseline in parent trial <br>2) Proportion of patients with PPP ASI50 compared to baseline in parent trial<br>3) Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear);Timepoint(s) of evaluation of this end point: 1) week 48, 96, 144, 192, 240 and 260<br>2) week 48, 96, 144, 192, 240 and 260<br>3) week 48, 96, 144, 192, 240 and 260<br>

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