Cerebral PalsyPhase 1NCT06377085

Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy

A Phase 1 study testing 5-Azacytidine 10mg/m^2 in people with Cerebral Palsy and Contracture, run by Shirley Ryan AbilityLab at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to… Read more about this study

Who is it for?: Ages 2 to 18 years
Conditions the study is for: Cerebral Palsy, Contracture
What is being tested?: 5-Azacytidine 10mg/m^2
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Jul 2025to Jul 2027
Phase: Phase 1
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 2 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Diagnosis of cerebral palsy.
Either achilles or hamstring spasticity with contracture necessitation surgical lengthening.
Between 2 and 18 years of age
Normal renal and liver function as defined by NCI-CTCAE criteria.71
Renal Function (Grade 0 - Normal): i. Creatinine: Within the normal range or ≤ 1.0 times the upper limit of normal (ULN).
Glomerular filtration rate (GFR): No significant decrease. b. Liver Function (Grade 0 - Normal): i. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT): Within the normal range or ≤ ULN.

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Total bilirubin: Within the normal range or ≤ 1.0 times ULN
A negative pregnancy test for females of childbearing potential*.
Females of childbearing potential must agree to use contraception consistently from screening to 6 months after their injection. Highly effective methods of contraception are required for females of childbearing potential:
Total abstinence from sexual intercourse.
Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal used in accordance with medical direction.
Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted, and used in accordance with medical direction.
Males of childbearing potential** must agree to use contraception consistently from screening until 3 months after the injection. Acceptable methods of contraception for males of childbearing potential are:
Total abstinence from sexual intercourse.
Condom with spermicide (cream, spray, foam, gel, suppository, or polymer film).
Female of childbearing potential is defined as a female capable of becoming pregnant, which includes patients who have had their first menstrual cycle (menarche).
Male of childbearing potential is defined as a subject who has reached spermarche.

Who cannot join

Active infection.
Cardiac disease.
Allergy to AZA or mannitol.
Patient or family who is non-compliant.
Received chemotherapy in the preceding three months.
Evidence of a hematologic precondition or other malignancy.

Trial locations and contacts

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

United States1 site

Rady Children's Hospital - San Diego
San Diego, California, 92123

Other trials in United States

About this study

The main questions this study aims to answer are:

What is the optimal dose of AZA injection that can be used safely in children with CP?
Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?

Each participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.

Researchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP.

Read the detailed description

Cerebral palsy (CP) has an enduring impact on the development of the muscles after birth. Research showed that a drug that is currently approved by the FDA to treat myelodysplastic syndromes in adults and children, can be potentially adapted ("repurposed") to support muscle growth. In a controlled dose-escalation study, we will study the preliminary safety, biological properties, and efficacy of this drug, called 5-Azacytidine (AZA). Our hope and overarching expectations are that one day AZA will become a new approved pharmacological treatment to support muscle growth and improve body movement and quality of life in children with CP.

Research participants will have five study visits.

The first study visit will be a screening within 30 days of the baseline visit and will determine eligibility for the study. The participant will have their blood drawn to check for normal kidney and liver functioning, do a pregnancy test (if applicable), and then the researcher will complete a medical assessment.
If the participant is eligible, they will be invited to a second study visit approximately 15 days prior to their scheduled surgery for contracture release. At this visit, the participants will get their blood drawn, do a pregnancy test (if applicable), have a medical assessment performed, and receive their injection. The injection will be a single sub-cutaneous shot in their leg, near the muscle group that will undergo surgical repair.
The third visit will be at the participant's scheduled surgery. A small sample of the muscle (i.e., about the size of a pencil eraser) will be surgically removed by the researcher from a muscle group that is already exposed during the procedure. The biopsy will add approximately two to five minutes to the overall procedure time. The participant will also have their blood drawn.
The participants will be seen approximately one week after their surgery to complete a medical assessment.
The last visit will be about four weeks after the surgery at their post-operative appointment. At this visit, the participant will have their blood drawn and complete a medical assessment to test their range of motion following the surgery.

The amount of blood drawn at each time point will be approximately 3 mL, equating to 12 mL of blood total (less than a tablespoon). The purpose of the blood draws is to evaluate safety and biological efficacy of the study drug. The medical assessment will consist of range of motion assessment and wound check performed by the clinicians. These are the same assessments that the clinicians would typically do as part of usual care prior to and after surgery. The purpose of the medical assessment is to evaluate the efficacy of the study drug and ensure the surgical site is healing.

Conditions: Cerebral Palsy, Contracture
Being tested: Placebo for the AZA 10mg/m^2, Placebo for the AZA 20mg/m^2, Placebo for the AZA 35mg/m^2, Placebo for the AZA 75mg/m^2, 5-Azacytidine 10mg/m^2
Keywords: 5-Azacytidine, Azacitidine, Contracture, Muscle
Medical subject headings: Cerebral Palsy, Contracture

What participants receive

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

Placebo for the AZA 10mg/m^2Drug
Placebo control group for the 10mg/m^2, one-time subcutaneous injection without the active treatment.
Placebo for the AZA 20mg/m^2Drug
Placebo control group for the 20mg/m^2, one-time subcutaneous injection without the active treatment.
Placebo for the AZA 35mg/m^2Drug
Placebo control group for the 35mg/m^2, one-time subcutaneous injection without the active treatment.
Placebo for the AZA 75mg/m^2Drug
Placebo control group for the 75mg/m^2, one-time subcutaneous injection without the active treatment.
5-Azacytidine 10mg/m^2Drug
5-Azacytidine 10mg/m^2, one-time subcutaneous injection
5-Azacytidine 20mg/m^2Drug
5-Azacytidine 20mg/m^2, one-time subcutaneous injection
5-Azacytidine 35mg/m^2Drug
5-Azacytidine 35mg/m^2, one-time subcutaneous injection
5-Azacytidine 75mg/m^2Drug
5-Azacytidine 75mg/m^2, one-time subcutaneous injection

Study groups in NCT06377085
Study group	Role	What they receive
AZA 10mg/m^2	Experimental	5-Azacytidine, subcutaneous injection, 10mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days) Receives: Drug: 5-Azacytidine 10mg/m^2
AZA 20mg/m^2	Experimental	5-Azacytidine, subcutaneous injection, 20mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days) Receives: Drug: 5-Azacytidine 20mg/m^2
AZA 35mg/m^2	Experimental	5-Azacytidine, subcutaneous injection, 35mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days) Receives: Drug: 5-Azacytidine 35mg/m^2
AZA 75mg/m^2	Experimental	5-Azacytidine, subcutaneous injection, 75mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days) Receives: Drug: 5-Azacytidine 75mg/m^2
Placebo for 10mg/m^2	Placebo comparator	Placebo, subcutaneous injection, 10mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days) Receives: Drug: Placebo for the AZA 10mg/m^2
Placebo for 20mg/m^2	Placebo comparator	Placebo, subcutaneous injection, 20mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days) Receives: Drug: Placebo for the AZA 20mg/m^2
Placebo for 35mg/m^2	Placebo comparator	Placebo, subcutaneous injection, 35mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days) Receives: Drug: Placebo for the AZA 35mg/m^2
Placebo for 75mg/m^2	Placebo comparator	Placebo, subcutaneous injection, 75mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days) Receives: Drug: Placebo for the AZA 75mg/m^2

What is being measured

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

Dose-limiting toxicity (DLT).
The percentage of patients experiencing DLT at the predefined dose level will be calculated.
This will determine the Maximum Tolerated Dose (MTD), which will be the highest dose level at which ≤ 33% of patients experience a DLT. DLT is defined as toxic effects, presumably related to AZA, considered unacceptable due to their severity and/or irreversibility, thereby limiting further dose escalation. Thus, the total number of toxicities and the DLT at each step of dose escalation and possible de-escalation will be reported. The scale for the primary endpoint is binary (occurrence of DLT or not). It is measured as a single endpoint, as it is focused on whether or not the predefined dose level causes DLT.
The currently recommended clinical dose is 75 mg/m2. For the present study, the following AZA concentrations will be evaluated: 10 mg/m2, 20 mg/m2, 35 mg/m2 and 75 mg/m2. For each dose, 3 experimental and 3 placebo subjects will be recruited.
Measured: Through study completion, an average of 2 years.

Secondary outcomes (3)

Satellite Cell Fusion Index.
Resident muscle-forming stem cells, called Satellite Cells, will be isolated from the muscle biopsy obtained from subjects and cultured in vitro. Satellite Cell Fusion Index quantifies the proportion of these stem cells that will fuse to form new muscle fibers in vitro (multinucleated structures called myotubes). It provides a measure of the efficiency of subjects' satellite cells to contribute to muscle growth, repair and regeneration.
Measured: Through study completion, an average of 2 years.
DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells.
Global DNA methylation analysis will be quantified (% tot DNA in ng) using DNA from Satellite Cell cultures and Blood Mononucleated Cells (isolated form blood) using an ELISA-based global DNA methylation kit.
Measured: Through study completion, an average of 2 years.
DNA methylation profiling in Satellite Cells.
Following Satellite Cell isolation, expansion in culture and DNA extractions, qualitative methylation analysis procedures will be conducted using an Infinium Human MethylationEPIC Beadchip array (Illumina Inc., CA), which targets over 850,000 DNA methylation sites at the dinucleotide (CpG) level throughout the entire genome.
Measured: Through study completion, an average of 2 years.

Timeline

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

Jul 2025Jul 2027

First posted22 Apr 2024
Study startJul 2025 (estimated)
Primary completionDec 2026 (estimated)
Study completionJul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cerebral PalsyStudies of the same condition, open and under way.
More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a "3 + 3" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT).
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 27 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06377085
Sponsor's protocol ID: 809325
Status last verified: Jun 2025
First submitted: 5 Mar 2024
Last updated: 3 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy
ClinicalTrials.gov ID: NCT06377085
Acronym / sponsor ID: 809325
Conditions: Cerebral Palsy, Contracture
Keywords: 5-Azacytidine, Azacitidine, Contracture, Muscle
Phase: Phase 1
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 27 participants (estimated)
Lead sponsor: Shirley Ryan AbilityLabUniversity, hospital or other
Collaborators: Rady Children's Hospital, San Diego
Study start: Jul 2025 (estimated)
Primary completion: Dec 2026 (estimated)
Study completion: Jul 2027 (estimated)
First posted: 22 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions this study aims to answer are:

What is the optimal dose of AZA injection that can be used safely in children with CP?
Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?

Detailed description

Research participants will have five study visits.

The first study visit will be a screening within 30 days of the baseline visit and will determine eligibility for the study. The participant will have their blood drawn to check for normal kidney and liver functioning, do a pregnancy test (if applicable), and then the researcher will complete a medical assessment.
If the participant is eligible, they will be invited to a second study visit approximately 15 days prior to their scheduled surgery for contracture release. At this visit, the participants will get their blood drawn, do a pregnancy test (if applicable), have a medical assessment performed, and receive their injection. The injection will be a single sub-cutaneous shot in their leg, near the muscle group that will undergo surgical repair.
The third visit will be at the participant's scheduled surgery. A small sample of the muscle (i.e., about the size of a pencil eraser) will be surgically removed by the researcher from a muscle group that is already exposed during the procedure. The biopsy will add approximately two to five minutes to the overall procedure time. The participant will also have their blood drawn.
The participants will be seen approximately one week after their surgery to complete a medical assessment.
The last visit will be about four weeks after the surgery at their post-operative appointment. At this visit, the participant will have their blood drawn and complete a medical assessment to test their range of motion following the surgery.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 8
Model description: For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a "3 + 3" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT).

Arm	Type	Receives
AZA 10mg/m^2	Experimental	Drug: 5-Azacytidine 10mg/m^25-Azacytidine, subcutaneous injection, 10mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days)
AZA 20mg/m^2	Experimental	Drug: 5-Azacytidine 20mg/m^25-Azacytidine, subcutaneous injection, 20mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days)
AZA 35mg/m^2	Experimental	Drug: 5-Azacytidine 35mg/m^25-Azacytidine, subcutaneous injection, 35mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days)
AZA 75mg/m^2	Experimental	Drug: 5-Azacytidine 75mg/m^25-Azacytidine, subcutaneous injection, 75mg/m^2, one subcutaneous injection for duration of study (estimated at 46 - 76 days)
Placebo for 10mg/m^2	Placebo comparator	Drug: Placebo for the AZA 10mg/m^2Placebo, subcutaneous injection, 10mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days)
Placebo for 20mg/m^2	Placebo comparator	Drug: Placebo for the AZA 20mg/m^2Placebo, subcutaneous injection, 20mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days)
Placebo for 35mg/m^2	Placebo comparator	Drug: Placebo for the AZA 35mg/m^2Placebo, subcutaneous injection, 35mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days)
Placebo for 75mg/m^2	Placebo comparator	Drug: Placebo for the AZA 75mg/m^2Placebo, subcutaneous injection, 75mg/m^2, one subcutaneous injection without the active treatment for duration of study (estimated at 46 - 76 days)

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (18 listed)

Diagnosis of cerebral palsy.
Either achilles or hamstring spasticity with contracture necessitation surgical lengthening.
Between 2 and 18 years of age
Normal renal and liver function as defined by NCI-CTCAE criteria.71
A negative pregnancy test for females of childbearing potential*.

Key exclusion criteria (6 listed)

Active infection.
Cardiac disease.
Allergy to AZA or mannitol.
Patient or family who is non-compliant.
Received chemotherapy in the preceding three months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo for the AZA 10mg/m^2Placebo control group for the 10mg/m^2, one-time subcutaneous injection without the active treatment.	Drug	Placebo for 10mg/m^2
Placebo for the AZA 20mg/m^2Placebo control group for the 20mg/m^2, one-time subcutaneous injection without the active treatment.	Drug	Placebo for 20mg/m^2
Placebo for the AZA 35mg/m^2Placebo control group for the 35mg/m^2, one-time subcutaneous injection without the active treatment.	Drug	Placebo for 35mg/m^2
Placebo for the AZA 75mg/m^2Placebo control group for the 75mg/m^2, one-time subcutaneous injection without the active treatment.	Drug	Placebo for 75mg/m^2
5-Azacytidine 10mg/m^25-Azacytidine 10mg/m^2, one-time subcutaneous injection	Drug	AZA 10mg/m^2
5-Azacytidine 20mg/m^25-Azacytidine 20mg/m^2, one-time subcutaneous injection	Drug	AZA 20mg/m^2
5-Azacytidine 35mg/m^25-Azacytidine 35mg/m^2, one-time subcutaneous injection	Drug	AZA 35mg/m^2
5-Azacytidine 75mg/m^25-Azacytidine 75mg/m^2, one-time subcutaneous injection	Drug	AZA 75mg/m^2

Primary outcome

Dose-limiting toxicity (DLT).
Time frame: Through study completion, an average of 2 years.
The percentage of patients experiencing DLT at the predefined dose level will be calculated. This will determine the Maximum Tolerated Dose (MTD), which will be the highest dose level at which ≤ 33% of patients experience a DLT. DLT is defined as toxic effects, presumably related to AZA, considered unacceptable due to their severity and/or irreversibility, thereby limiting further dose escalation. Thus, the total number of toxicities and the DLT at each step of dose escalation and possible de-escalation will be reported. The scale for the primary endpoint is binary (occurrence of DLT or not). It is measured as a single endpoint, as it is focused on whether or not the predefined dose level causes DLT. The currently recommended clinical dose is 75 mg/m2. For the present study, the following AZA concentrations will be evaluated: 10 mg/m2, 20 mg/m2, 35 mg/m2 and 75 mg/m2. For each dose, 3 experimental and 3 placebo subjects will be recruited.

3 secondary outcomes

Satellite Cell Fusion Index.
Time frame: Through study completion, an average of 2 years.
DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells.
Time frame: Through study completion, an average of 2 years.
DNA methylation profiling in Satellite Cells.
Time frame: Through study completion, an average of 2 years.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Andrea Domenighetti, PhD principal investigator

Shirley Ryan AbilityLab

Patrick Curran, MD principal investigator

Rady Children's Hospital, San Diego

Richard L. Lieber, PhD principal investigator

Shirley Ryan AbilityLab

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5-Azacytidine 10mg/m^2 in people with Cerebral Palsy and Contracture, run by Shirley Ryan AbilityLab at 1 site in United States.

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 18 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT). (time frame: Through study completion, an average of 2 years.). 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 NCT06377085.

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 3 Jul 2025.