Post-polio SyndromePhase 2/3FORCENCT02176863
Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% Dual Inactivation and Filtration (DIF) in Participants With Post-polio Syndrome
A Phase 2/3 study testing Flebogamma® 5% DIF in people with Post-polio Syndrome, run by Instituto Grifols, S.A. at 21 sites in 9 countries.
Trial summary
This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-polio Syndrome
- What is being tested?
- Flebogamma® 5% DIF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 23 Sep 2014to 24 Nov 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with Body Mass Index less than 35 kg/m^2.
- Participants who meet the clinical criteria for diagnosis of PPS as set by March-of-Dimes.
- Participants who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
- Participants who have at least 2 newly weakened muscle groups due to PPS (as defined by medical history), with at least 1 of them in a lower extremity, and having a Medical Research Council (MRC) scale score greater than 3 at the Manual Muscle Testing (MMT) performed by the independent assessor at the Screening Visit (SV).
- Female of child-bearing potential must have a negative test for pregnancy (Human chorionic gonadotropin (HCG)-based assay).
- Female of child-bearing potential and their sexual partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a pregnancy during the course of the clinical trial.
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- Participants must be willing to comply with all aspects of the clinical trial protocol, including blood sampling and long-term storage of extra samples for the entire duration of the study.
- Participants who are able to walk a 2MWD of at least 50 meters at the SV and Enrollment Visit/Infusion Visit 1 (EV/IV1)
- Participants who are able to walk a consistent baseline 2 MWD, that is, the difference in 2MWD between the SV and EV/IV1 is not more than 10%.
Who cannot join
- Participants who have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years.
- Participants who are not ambulatory (wheelchair-bound individuals).
- Participants with poor venous access.
- Participants with intractable pain requiring narcotics or other psychotropic drugs.
- Participants with a history of anaphylactic reactions or severe reactions to any blood-derived product.
- Participants with a history of intolerance to any component of the investigational products, such as sorbitol.
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- Participants receiving corticosteroids, except for those who are taking inhaled corticosteroids for asthma.
- Participants with a documented diagnosis of hyper viscosity or hypercoagulable state or thrombotic complications to polyclonal intravenous immunoglobulin (IVIG) therapy in the past.
- Participants with a history of recent (within the last year) myocardial infarction, stroke, or uncontrolled hypertension.
- Participants who suffer from congestive heart failure, embolism, or electrocardiogram changes indicative of unstable angina or atrial fibrillation.
- Participants with a history of chronic alcoholism or illicit drug abuse (addiction) in the preceding 12 months prior to the SV.
- Participants with active psychiatric illness that interferes with compliance or communication with health care personnel.
- Participants with depression with scores >30 as assessed by the Center for Epidemiologic Studies Depression (CESD) validated scale.
- Females who are pregnant or are nursing an infant child.
- Participants with any medical condition which makes clinical trial participation unadvisable or which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the clinical trial according to the Investigator's judgment.
- Participants currently receiving, or have received within 3 months prior to the SV, any investigational medicinal product or device.
- Participants who are unlikely to adhere to the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum/plasma sample prior to the first investigational drug infusion.
- Participants with known selective Immune globulin A class (IgA) deficiency and serum antibodies anti-IgA.
- Participants with renal impairment (i.e., serum creatinine exceeds more than 1.5 times the upper limit of normal [ULN]) for the expected normal range for the testing laboratory).
- Participants with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN.
- Participants with hemoglobin levels <10 g/dL, platelets levels <100,000 /mm^3, white blood cells count <3.0 k/µL, and erythrocyte sedimentation rate >50 mm/h or twice above normal.
- Participants with known seropositive to Hepatitis C virus (HCV), Human immunodeficiency virus-1 (HIV-1) and/or Human immunodeficiency virus-2 (HIV-2).
- Participants with a history of intolerance to fructose.
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
Germany5 sites
Charité Campus Mitte
Berlin, 10117
Hannover Medical School
Hanover, 30625
Universitätsklinikum Jena
Jena, 07747
Klinik für konservative Orthopädie und des Poliozentrums
Koblenz, 56073
Westfälische Wilhelms-Universität Münster
Münster, 48149
United States4 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Washington University
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
Poland4 sites
MedTrials
Krakow, 31-436
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Clinical Research Center Sp. z o.o.
Poznan, 60-848
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, 02-097
Denmark2 sites
Aarhus Universitets Hospital-Neurologisk Forskning
Aarhus N, 8200
Rigshospitalet
København Ø, 2100
Spain2 sites
Institut Guttman
Badalona, 08916
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Canada1 site
Montreal Neurological Institute Clinical Research Unit, McGill University
Montreal, Quebec, H3A 2B4
Czechia1 site
Thomayerova nemocnice, Klinicko-farmakologická jednotka
Prague, 4
Italy1 site
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)
Verona, 37124
Netherlands1 site
Academisch Medisch Centrum Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
About this study
Official title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Participants With Post-Polio Syndrome
This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS).
The main purpose of this study was to select a dose of Flebogamma® 5% DIF and confirm the efficacy of the selected Flebogamma® 5% DIF dose by assessing physical performance, as measured by Two-Minute Walk Distance (2MWD) test.
The study consisted of 2 stages, with each stage consisting of a screening period (up to 4 weeks), a treatment period (52 weeks), and a follow-up period (24 weeks).
- Conditions
- Post-polio Syndrome
- Being tested
- Flebogamma® 5% DIF, Placebo
- Keywords
- FORCE, Post-polio syndrome, Flebogamma®, Immune Globulin Intravenous, IVIG
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flebogamma® 5% DIFBiological
Also called immune globulin intravenous (human)
Human plasma-derived immunoglobulin
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF | Experimental | Participants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks. Receives: Biological: Flebogamma® 5% DIF |
| Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF | Experimental | Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period. Receives: Biological: Flebogamma® 5% DIF; Drug: Placebo |
| Stage 1 Arm 3: Placebo | Placebo comparator | Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks. Receives: Drug: Placebo |
| Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF | Experimental | Participants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period. Receives: Biological: Flebogamma® 5% DIF; Drug: Placebo |
| Stage 2 Arm 2: Placebo | Placebo comparator | Participants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test
The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.
Measured: Baseline to Week 52
Secondary outcomes (3)
Change From Baseline in Pain Using Visual Analogue Scale (VAS) of Pain
VAS is a participant self-reported pain scale used to evaluate the pain level in a 24 hours period. The scale consists of a 100 millimeters (mm) scale where 100 mm stands for the worst imaginable pain and zero stands for no pain. Higher scores indicate severe pain. A negative change from baseline indicates improvement. LS mean and 95% (CI) were based on MMRM method.
Measured: Baseline to Week 52
Change From Baseline in Health-Related Quality of Life (HRQoL) Assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
HRQoL SF-36 is participant self-reported survey.It yields 8-scale profile of functional health and well-being as well as physical and mental health summary measures. It consists of the subscales:physical functioning,limitations due to physical health,body pain,general health,vitality,social functioning,emotional problems, and mental health. Each domain score ranges from 0(worst) to 100(best),higher scores reflect better functional status.PCS is a subscale score \& give broader metric of physical HRQoL.PCS score ranges from 0 to 100 and is computed such that mean score of 50 corresponds to the general US population.Based on norm-based scoring,scores above 50 is better-than-average health \& below 50 is below-average health.Higher scores represents better physical health.Positive change from baseline indicates improvement.LS mean and 95% CI were based on MMRM.
Measured: Baseline to Week 52
Change From Baseline in Endurance Assessed by Six-Minute Walk Distance (6MWD) Test
The 6MWD was used to assess physical performance by measuring the distance that a patient can quickly walk at maximal speed on a flat, hard surface 30 m (100-ft) hallway in a period of 6 minutes. A positive change from baseline indicates improvement (i.e., a patient can walk farther). Increase from baseline in distance walked (in meters) indicated improvement. LS mean and 95% CI were based on MMRM method.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study start23 Sep 2014
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Why it stopped: Due to Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-polio SyndromeStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marinos Dalakas, MD, Principal investigator, Coordinating Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176863
- Sponsor's protocol ID
- IG1104
- Other IDs
- 2013-004503-39
- Acronym
- FORCE
- Status last verified
- Nov 2025
- First submitted
- 25 Jun 2014
- Last updated
- 5 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Participants With Post-Polio Syndrome
- ClinicalTrials.gov ID
- NCT02176863
- Acronym / sponsor ID
- FORCE / IG1104
- Conditions
- Post-polio Syndrome
- Keywords
- FORCE, Post-polio syndrome, Flebogamma®, Immune Globulin Intravenous, IVIG
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to Business Decision
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 5 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, prospective, randomized, placebo-controlled, double-blind, parallel group clinical trial with adaptive dose selection in participants with post-polio syndrome (PPS).
The main purpose of this study was to select a dose of Flebogamma® 5% DIF and confirm the efficacy of the selected Flebogamma® 5% DIF dose by assessing physical performance, as measured by Two-Minute Walk Distance (2MWD) test.
The study consisted of 2 stages, with each stage consisting of a screening period (up to 4 weeks), a treatment period (52 weeks), and a follow-up period (24 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF | Experimental | Biological: Flebogamma® 5% DIFParticipants received Flebogamma® 5% DIF 2 g/kg of body weight administered via intravenous (IV) infusion over 2 consecutive days (Flebogamma® 5% DIF 1 g/kg infused on Day 1, followed by Flebogamma® 5% DIF 1 g/kg infused on Day 2) every 4 weeks for 52 weeks. |
| Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF | Experimental | Biological: Flebogamma® 5% DIF, Drug: PlaceboParticipants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period. |
| Stage 1 Arm 3: Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks. |
| Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF | Experimental | Biological: Flebogamma® 5% DIF, Drug: PlaceboParticipants received Flebogamma® 5% DIF 1 g/kg of body weight administered via IV infusion on Day 1, followed by 20 mL/kg of matching placebo administered on a separate day, for a total dosing period of 2 consecutive days, every 4 weeks for 52 weeks. The order of 1 g/kg of Flebogamma® 5% DIF or matching placebo was randomly determined for each participant and was the same for the participant for all infusion visits during the treatment period. |
| Stage 2 Arm 2: Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo at a total dose of 40 mL/kg of body weight administered via IV infusion over 2 consecutive days. On Day 1, a dose of 20 mL/kg of matching placebo was given, followed by the second dose of 20 mL/kg of matching placebo on Day 2, administered every 4 weeks for 52 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants with Body Mass Index less than 35 kg/m^2.
- Participants who meet the clinical criteria for diagnosis of PPS as set by March-of-Dimes.
- Participants who are ambulatory or are able to walk with a cane or other aids or use a wheelchair (but they are not wheelchair-bound).
- Participants who have at least 2 newly weakened muscle groups due to PPS (as defined by medical history), with at least 1 of them in a lower extremity, and having a Medical Research Council (MRC) scale score greater than 3 at the Manual Muscle Testing (MMT) performed by the independent assessor at the Screening Visit (SV).
- Female of child-bearing potential must have a negative test for pregnancy (Human chorionic gonadotropin (HCG)-based assay).
Key exclusion criteria (23 listed)
- Participants who have received human normal immune globulin treatment given by intravenous, subcutaneous, or intramuscular route within the last 3 years.
- Participants who are not ambulatory (wheelchair-bound individuals).
- Participants with poor venous access.
- Participants with intractable pain requiring narcotics or other psychotropic drugs.
- Participants with a history of anaphylactic reactions or severe reactions to any blood-derived product.
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 |
|---|---|---|
| Flebogamma® 5% DIFAlso: immune globulin intravenous (human)Human plasma-derived immunoglobulin | Biological | Stage 1 Arm 1: 2 g/kg Flebogamma® 5% DIF, Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF, Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF |
| PlaceboMatching placebo | Drug | Stage 1 Arm 2: 1 g/kg Flebogamma® 5% DIF, Stage 1 Arm 3: Placebo, Stage 2 Arm 1: 1 g/kg Flebogamma® 5% DIF, Stage 2 Arm 2: Placebo |
Primary outcome
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test
Time frame: Baseline to Week 52
The 2MWD was used to assess physical performance by measuring the distance that a participant can quickly walk at a self-preferred speed on an indoor flat, hard surface 30 m (100-ft) hallway in a period of 2 minutes. A positive change from baseline indicates improvement (i.e. a patient can walk farther). Increase in distance walked (in meters) indicates improvement.
3 secondary outcomes
Change From Baseline in Pain Using Visual Analogue Scale (VAS) of Pain
Time frame: Baseline to Week 52
Change From Baseline in Health-Related Quality of Life (HRQoL) Assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
Time frame: Baseline to Week 52
Change From Baseline in Endurance Assessed by Six-Minute Walk Distance (6MWD) Test
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Marinos Dalakas, MD principal investigator
Coordinating Investigator
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Flebogamma® 5% DIF in people with Post-polio Syndrome, run by Instituto Grifols, S.A. at 21 sites in 9 countries.
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 9 inclusion and 23 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: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, United States, Poland, Denmark, Spain and 4 more countries. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Physical Performance Assessed by Two-Minute Walk Distance (2MWD) Test (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.