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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04493424
Collaborator
(none)
500
Enrollment
66
Locations
1
Arm
106.6
Anticipated Duration (Months)
7.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
Actual Study Start Date :
Sep 4, 2020
Anticipated Primary Completion Date :
Mar 25, 2029
Anticipated Study Completion Date :
Jul 25, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Up to 260 weeks

Drug: Spesolimab
Spesolimab

Outcome Measures

Primary Outcome Measures

  1. Occurrence of treatment emergent adverse events (TEAEs) [Up to week 260]

Secondary Outcome Measures

  1. Percent change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) from baseline in parent trial [Up to week 260]

  2. Proportion of patients with Palmoplantar Pustulosis Area and Severity Index 50% (PPP ASI50) compared to baseline in parent trial [Up to week 260]

  3. Proportion of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) of 0 (clear) or 1 (almost clear) [Up to week 260]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Total Skin and Beauty Dermatology Center, PC Birmingham Alabama United States 35205
2 University of Missouri Health System Columbia Missouri United States 65212
3 The Psoriasis Treatment Center of Central New Jersey East Windsor New Jersey United States 08520
4 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
5 Menter Dermatology Research Institute Dallas Texas United States 75246
6 University of Utah Health Murray Utah United States 84107
7 Paratus Clinical Research Woden Phillip Australian Capital Territory Australia 2606
8 Westmead Hospital Westmead New South Wales Australia 2145
9 Skin Health Institute Inc Carlton Victoria Australia 3053
10 Royal Melbourne Hospital Parkville Victoria Australia 3050
11 Brussels - UNIV Saint-Luc Bruxelles Belgium 1200
12 UZ Leuven Leuven Belgium 3000
13 Dr. Irina Turchin PC Inc. Fredericton New Brunswick Canada E3B 1G9
14 SimcoDerm Medical and Surgical Dermatology Centre Barrie Ontario Canada L4M 7G1
15 The Guenther Dermatology Research Centre London Ontario Canada N6A 3H7
16 Innovaderm Research Inc. Montreal Quebec Canada H2X 2V1
17 CCBR Czech a.s. Pardubice Czechia 530 02
18 Sanatorium Prof. Arenebergera Prague Czechia 11000
19 Univ. Hospital Kralovske Vinohrady Praha Czechia 100 34
20 HOP l'Archet Nice France 06200
21 HOP Saint-Louis Paris France 75010
22 HOP Larrey Toulouse France 31059
23 Charité - Universitätsmedizin Berlin Berlin Germany 10117
24 Universitätsklinikum Erlangen Erlangen Germany 91054
25 Universitätsklinikum Frankfurt Frankfurt am Main Germany 60596
26 Universitätsklinikum Heidelberg Heidelberg Germany 69120
27 Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany 24105
28 University of Pecs Pecs Hungary 7632
29 Markusovszky University Teaching Hospital Szombathely Hungary 9700
30 Fujita Health University Hospital Aichi, Toyoake Japan 470-1192
31 Tokyo Dental College Ichikawa General Hospital Chiba, Ichikawa Japan 272-8513
32 Fukuoka University Hospital Fukuoka, Fukuoka Japan 814-0180
33 Gifu University Hospital Gifu, Gifu Japan 501-1194
34 Asahikawa Medical University Hospital Hokkaido, Asahikawa Japan 078-8510
35 Takagi Dermatological Clinic Hokkaido, Obihiro Japan 080-0013
36 Takamatsu Red Cross Hospital Kagawa, Takamatsu Japan 760-0017
37 Sagamihara National Hospital Kanagawa, Sagamihara Japan 252-0392
38 Kumamoto University Hospital Kumamoto, Kumamoto Japan 860-8556
39 University Hospital Kyoto Prefectural University of Medicine Kyoto, Kyoto Japan 602-8566
40 Tohoku University Hospital Miyagi, Sendai Japan 980-8574
41 Shinshu University Hospital Nagano, Matsumoto Japan 390-8621
42 Okayama University Hospital Okayama, Okayama Japan 700-8558
43 University of the Ryukyus Hospital Okinawa, Nakagami-gun Japan 903-0215
44 Nakatsu Dermatology Clinic Osaka, Osaka Japan 531-0072
45 Osaka Metropolitan University Hospital Osaka, Osaka Japan 545-8586
46 Osaka University Hospital Osaka, Suita Japan 565-0871
47 Shiga University of Medical Science Hospital Shiga, Otsu Japan 520-2192
48 Jichi Medical University Hospital Tochigi, Shimotsuke Japan 329-0498
49 Teikyo University Hospital Tokyo, Itabashi-ku Japan 173-8606
50 Nihon University Itabashi Hospital Tokyo, Itabashi-ku Japan 173-8610
51 Tokyo Medical University Hospital Tokyo, Shinjuku-ku Japan 160-0023
52 Wakayama Medical University Hospital Wakayama, Wakayama Japan 641-8509
53 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
54 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620
55 Seoul National University Hospital Seoul Korea, Republic of 03080
56 Barbara Rewerska Diamond Clinic, Krakow Krakow Poland 31-559
57 Dermoklinika medical center, Lodz Lodz Poland 90-436
58 Independent Public Clin.Hosp.no1 Lublin Lublin Poland 20-081
59 Municipal Hospital Complex in Olsztyn Olsztyn Poland 10-229
60 Dermmedica Sp. z o.o., Wroclaw Wroclaw Poland 51-318
61 SBHI Chelyabinsk Reg.Clin.Derma.Dispen. Chelyabinsk Russian Federation 454048
62 LLC "Medical Center Azbuka Zdorovia" Kazan Russian Federation 420111
63 Dermatovenereological Dispensary #10, St. Petersburg Saint-Petersburg Russian Federation 194021
64 National Taiwan University Hospital Taipei Taiwan 10002
65 Royal Devon and Exeter Hospital Exeter United Kingdom EX2 5DW
66 Guy's Hospital London United Kingdom SE1 9RT

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04493424
Other Study ID Numbers:
  • 1368-0024
  • 2020-000189-41
First Posted:
Jul 30, 2020
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Aug 10, 2022