AzTrials
AzTrials

Ischemic StrokePhase 2ReSCInDNCT05880524

Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

A Phase 2 study testing Dornase Alfa and Isotonic Saline Solution in people with Ischemic Stroke and Inflammatory Response, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this (multicentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Inflammatory Response
What is being tested?
Dornase Alfa and Isotonic Saline Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
5 sitesGermany
Study dates
1 Oct 2026to Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with suspected acute ischemic stroke with symptom onset (last-seen-well) until Investigational drug application of less than 12 hours.
  • Consent to participate in the study.
  • Age ≥ 18 years.
  • NIHSS ≥10 at admission.

Who cannot join

  • Presence of any of the following conditions: Sinus or cerebral venous thrombosis, intracerebral haemorrhage, subarachnoid haemorrhage on qualified imaging (cCT with CT-A or MRI with MR-A). However, petechial haemorrhagic transformations of the index infarct and cerebral microhaemorrhages may be included.
  • Active malignant tumour disease in the last 6 months.
  • Current known immunosuppression due to immunomodulatory medication with immunosuppressive dose or underlying immunosuppressive disease (e.g. HIV).
  • Acute fulminant infectious disease in the last 7 days (fever > 38.5°C or suspected by the Investigator).
  • Breastfeeding or pregnant woman, women of childbearing age without known use of contraceptives with positive urine or serum beta-human choriogonadotropin test.
  • Ischemic stroke or myocardial infarction in the previous 30 days.
Show all 12Show fewer
  • Surgery in the previous 30 days, except minor dermatological or gynaecological surgery without anaesthesia and wound healing disorders and patients with thrombectomy.
  • Estimated or known weight > 100 kg.
  • Known allergies or intolerance to dornase alfa (Pulmozyme) or recombinant protein products derived from Chinese hamster ovary cells.
  • Thrombocytopenia, leukocyte count <1500/μl.
  • Known participation in another clinical trial investigating a drug and/or medical product in the last 7 days before study inclusion.
  • Severe renal insufficiency with GFR≤29 ml/min/ 1.73m³ and/or renal insufficiency requiring dialysis.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Arthur Liesz, Prof. Dr. contact

+49 89 4400 46169

arthur.liesz@med.uni-muenchen.de

5 sites in 1 country

Germany5 sites, 5 recruiting

  • Charité Universitätsmedizin

    Berlin

    Matthias Endres, Prof. Dr. med., +49 30 450 560 102, matthias.endres@charite.de

    Recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg

    Götz Thomalla, Prof. Dr. med., +49-40-7410-53770, thomalla@uke.de

    Recruiting

  • MHH Hannover

    Hanover

    Ramona Schuppner, Dr. med., +49 511-532-2392, Schuppner.Ramona@mh-hannover.de

    Recruiting

  • Institute for Stroke and Dementia Research, Ludwig Maximilian University Munich, University Hospital

    Munich, Bavaria, 81377

    Arthur Liesz, Prof. Dr., +49 89 4400 46169, arthur.liesz@med.uni-muenchen.de

    Martin Dichgans, Prof. Dr.

    Not yet recruiting

  • TUM Klinikum München

    Munich

    Silke Wunderlich, Prof. Dr. med., +49 89 4140-5069, silke.wunderlich@tum.de

    Not yet recruiting

Other trials in Germany

About this study

The goal of this (multicentric, randomised, placebo-controlled single-blinded; phase 2) clinical trial is to test the hypothesis that DNase 1 administration leads to a reduction in systemic immune response measured in patients after acute ischaemic stroke compared to control treatment.

Participants will receive intravenous DNase 1 (500 µg/kg) or placebo (NaCl 0.9%) twice within 24±6 hours after symptom onset (last seen well). Blood samples will be taken at baseline, day 1 and 3. Personal visits will occur on baseline, day 1, 3 and discharge date. A telephone interview will be conducted on day 30±3.

Being tested
Dornase Alfa, Isotonic Saline Solution
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dornase AlfaDrug

    Also called Pulmozyme

    Patients will receive an intravenous dose of Dornase alfa twice within within 24±6 hours after symptom onset, administered as a bolus.

  • Isotonic Saline SolutionDrug

    Also called NaCl 0,9%

    Patients will receive an intravenous dose of Isotonic saline solution twice within within 24±6 hours after symptom onset, administered as a bolus.

Study groups in NCT05880524
Study groupRoleWhat they receive
PulmozymeActive comparatorDornase alfa; intravenous administration; 500 µg/kg
Receives: Drug: Dornase Alfa
Isotonic Saline SolutionPlacebo comparatorNaCl 0,9 %; intravenous administration; 0,5 ml/kg
Receives: Drug: Isotonic Saline Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of interleukin-1 beta in blood of patients with acute ischemic stroke receiving Dornase alfa compared to placebo treatment with Isotonic Saline Solution.

    Outcome of reduced systemic immune response measured by interleukin-1 beta concentration [pg/ml] (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).

    Measured: 24±6 hours after symptom onset

Secondary outcomes (9)

  1. cfDNA concentration in blood.

    Measurement of cell-free DNA (cfDNA) concentration [ng/ml] in blood at day 1 (24±6 hours after symptom onset) compared to the placebo group with experimental analysis.

    Measured: 24±6 hours after symptom onset

  2. DNase 1 activity in blood.

    Comparison of DNase 1 activity [µU/ml] in blood of both treatment arms measured by Enzyme-linked Immunosorbent Assay (ELISA).

    Measured: 24±6h after symptom onset

  3. Concentration of DNase 1 in blood.

    Analysis of the DNase 1 concentration [ng/ml] in patient blood treated with Dornase alfa compared to the placebo group by Enzyme-linked Immunosorbent Assay (ELISA).

    Measured: 24±6h after symptom onset

  4. Analysis of the composition of the leukocyte population in blood.

    Analysing the leukocyte population [%] in blood using flow cytometry in both treatment arms.

    Measured: 24±6 hours after symptom onset

  5. Interleukin-6 concentration in blood after treatment.

    Measurement of the interleukin-6 concentration [pg/ml] in blood samples (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).

    Measured: 24±6 hours after symptom onset

  6. Caspase 1 concentration in blood after treatment.

    Analysing the caspase 1 concentration [pg/ml] in blood (at 24±6 hours after symptom onset) measured by Enzyme-linked Immunosorbent Assay (ELISA).

    Measured: 24±6 hours after symptom onset

  7. Assessment of patient safety after Dornase alfa treatment.

    Safety aspects of intravenous investigational drug administration in acute ischemic stroke patients will be assessed by monitoring all study patients for 30±3 days and analysis of their:

    • routine clinical diagnostics (worsening stroke is defined as a) progression, hemorrhagic transformation of the index stroke documented by radiological imaging; b) life-threatening need for intervention; c) death from the index stroke; and/or d) increasing disability (as measured by an increase of ≥ 4 points from the lowest NIHSS score measured during hospitalization, or a 1-point increase in mRS),
    • laboratory parameters (hemoglobin, platelets, neutrophil granulocytes, leukocytes, CRP, GFR, creatinine, IL-6) and
    • number of adverse events assessed by CTCAE current version.

    Measured: 30±3 days after symptom onset

  8. Comparison of the incidence of infections and antibiotic treatment in both treatment arms.

    Comparing the incidence of infections and antibiotic treatment after Dornase alfa and Isotonic Saline Solution treatment over a period of 30±3 days after symptom onset.

    Measured: 30±3 days after symptom onset

  9. Functional neurological outcome scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) at both treatment arms.

    Analysing changes of neurological scores (National Institute of Health Stroke Scale [NIHSS, 0-42] and Modified Rankin Scale [mRS, 0-6]) from baseline to last visit 30±3 days after symptom onset.

    Measured: 30±3 days after symptom onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start1 Oct 2026 (estimated)
  3. Primary completionMar 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentric, randomised, placebo-controlled single-blinded, Phase 2 trial
Masking
Single blind
Who is masked
Participant
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05880524
Sponsor's protocol ID
RESCIND-1-2023
Other IDs
2024-516701-22-00
Acronym
ReSCInD
Status last verified
Sep 2026
First submitted
30 Apr 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharma N, Dwivedi DJ, Fux L, Hayon Y, Ruderfer I, Nataf Y, Cani E, Liaw PC. Intravenous Delivery of Long-Acting Dnase I (PRX-119) In a Murine Model of Polymicrobial Abdominal Sepsis. Shock. 2026 Jan 1;65(1):76-84. doi: 10.1097/SHK.0000000000002666. Epub 2025 Jul 8.

    PubMed 40705350

  • Di G, Vazquez-Reyes S, Diaz B, Pena-Martinez C, Garcia-Culebras A, Cuartero MI, Moraga A, Pradillo JM, Esposito E, Lo EH, Moro MA, Lizasoain I. Daytime DNase-I Administration Protects Mice From Ischemic Stroke Without Inducing Bleeding or tPA-Induced Hemorrhagic Transformation, Even With Aspirin Pretreatment. Stroke. 2025 Feb;56(2):527-532. doi: 10.1161/STROKEAHA.124.049961. Epub 2025 Jan 27.

    PubMed 39869712

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dornase Alfa and Isotonic Saline Solution in people with Ischemic Stroke and Inflammatory Response, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Arthur Liesz, Prof. Dr. (+49 89 4400 46169, arthur.liesz@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of interleukin-1 beta in blood of patients with acute ischemic stroke receiving Dornase alfa compared to placebo treatment with Isotonic Saline Solution. (time frame: 24±6 hours after symptom onset). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05880524, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in