A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Phase 2TerminatedNCT04493424

Boehringer Ingelheim108 enrolled

Overview

This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Palmoplantar Pustulosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 at screening, 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 * Further exclusion criteria apply

Locations (66)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

University of Missouri Health System

Columbia, Missouri, United States

The Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Outcomes

Primary Outcomes

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.

Time frame: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.

Secondary Outcomes

Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96

Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial \* 100%.

Time frame: Week 0 (baseline) and Week 48, Week 96

Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96

Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.

Time frame: Week 0 (baseline) and Week 48, Week 96

Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96

Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation. The PPP PGA total score was derived as the mean of all individual components: 0 = If mean=0, for all three components: 1. = If 0 \< mean \<1.5 2. = If 1.5 \<= mean \<2.5 3. = If 2.5 \<= mean \<3.5 4. = If mean \>=3.5

Time frame: Week 48 and Week 96