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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06624670




Registration number
NCT06624670
Ethics application status
Date submitted
30/09/2024
Date registered
3/10/2024
Date last updated
19/11/2024

Titles & IDs
Public title
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Scientific title
A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy
Secondary ID [1] 0 0
2024-514306-31-00
Secondary ID [2] 0 0
1368-0140
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pyoderma Gangrenosum 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab
Treatment: Drugs - Placebo matching to spesolimab
Treatment: Drugs - Prednisone
Treatment: Drugs - Prednisolone

Experimental: Spesolimab -

Placebo comparator: Placebo -


Treatment: Drugs: Spesolimab
Solution for infusion

Treatment: Drugs: Placebo matching to spesolimab
Placebo matching to spesolimab

Treatment: Drugs: Prednisone
Prednisone

Treatment: Drugs: Prednisolone
Prednisolone
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to Week 28.
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to Week 28.
Secondary outcome [2] 0 0
Achievement of PGAR-100 of any measurable PG ulcer (=5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Timepoint [2] 0 0
Up to Week 28.
Secondary outcome [3] 0 0
Achievement of PGAR-100 of all measurable PG ulcers (=5 cm^2 at baseline) at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)
Timepoint [3] 0 0
Up to Week 28.
Secondary outcome [4] 0 0
Achievement of =3-point reduction in NRS (Numeric Rating Scale) Pain score from baseline at Week 4
Timepoint [4] 0 0
At baseline and at Week 4.
Secondary outcome [5] 0 0
Time to recurrence among trial participants who had achieved complete response (CR, complete closure of all PG ulcers) at Week 26 up to Week 52
Timepoint [5] 0 0
Up to Week 52.

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Adult trial participants, aged =18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
2. 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.
3. 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.
4. At least one measurable (defined as measuring =5 cm^2) 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.
5. At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers >6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
6. Women of childbearing potential (WOCBP) 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 and instructions on the duration of use is provided in the participant information and in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Trial participants with non-PG lesions.
2. Trial participants with a target PG ulcer measuring >80 cm^2.
3. Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
4. 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.
5. Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed =2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit 2.
6. "Active or latent tuberculosis (TB)

* Participants with active TB are excluded
* Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial."
7. Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
8. Severe, progressive, or uncontrolled hepatic disease, defined as >3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or >2x ULN elevation in total bilirubin.

Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
17/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/10/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Skin and Cancer Foundation - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Hospital-St Leonards-20807 - St Leonards
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Florida
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Indiana
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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New Hampshire
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New York
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North Dakota
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Ohio
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Oregon
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Texas
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United States of America
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Utah
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Argentina
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Caba
Country [17] 0 0
Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Rosario
Country [19] 0 0
Austria
State/province [19] 0 0
Graz
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Austria
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Linz
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Austria
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Salzburg
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Belgium
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Leuven
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Brazil
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Brasilia
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Brazil
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Santo André
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
State/province [27] 0 0
Quebec
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China
State/province [28] 0 0
Beijing
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China
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Changsha
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China
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Chengdu
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China
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Hangzhou
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China
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Jilin
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China
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Jinan
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China
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Shanghai
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China
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Shenzhen
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China
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Urumqi
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China
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Wuhan
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China
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Xi'an
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Finland
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Helsinki
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France
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Antony
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France
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Lyon
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France
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Nice Cedex 3
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France
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Paris
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Freiburg
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Germany
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München
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Germany
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Würzburg
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Italy
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Messina
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Italy
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Milano
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Italy
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Pisa
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Italy
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Roma
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Italy
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Rozzano (MI)
Country [56] 0 0
Italy
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Torino
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Japan
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Aichi, Toyoake
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Japan
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Hokkaido, Sapporo
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Japan
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Hyogo, Nishinomiya
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Japan
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Mie, Tsu
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Japan
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Miyagi, Sendai
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Japan
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Tochigi, Shimotsuke
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Japan
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Tokyo, Itabashi-ku
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Japan
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Tokyo, Itabashi
Country [65] 0 0
Malaysia
State/province [65] 0 0
Ipoh
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Malaysia
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Kuching
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Malaysia
State/province [67] 0 0
Pulau Pinang
Country [68] 0 0
Norway
State/province [68] 0 0
Oslo
Country [69] 0 0
Norway
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Stavanger
Country [70] 0 0
Poland
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Olsztyn
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Poland
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Warsaw
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Poland
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Wroclaw
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Puerto Rico
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Caguas
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Spain
State/province [78] 0 0
Madrid
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Spain
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Malaga
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockholm
Country [81] 0 0
Switzerland
State/province [81] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 injections look like spesolimab injections, 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.
Trial website
https://clinicaltrials.gov/study/NCT06624670
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06624670