Last reviewed · How we verify
Anakinra for the Treatment of Chronically Inflamed White Matter Lesions in Multiple Sclerosis
Phase 1, PHASE2 trial testing Anakinra in Multiple Sclerosis in 8 participants. Completed in 24 October 2023.
| Lead sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 25 October 2019 |
| Primary completion | 24 October 2023 |
| Estimated completion | 24 October 2023 |
| Sites | 1 location across United States |
National Institute of Neurological Disorders and Stroke (NINDS)
Adults 18 to 120, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of lesions in which the paramagnetic rim has been modulated at the end of the dosing period.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | .04 |
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. The test is administered by asking the participant to take pegs from a container, one by one, and place them into holes on a board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. The test is timed with a lower number suggesting faster finger dexterity and a higher number suggesting slower finger dexterity. The results represent the mean change from baseline to end of dosing.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | -0.42 | ± 1.51 |
The Symbol Digit Modalities Test (SDMT) is a neuropsychological test that assesses cognitive status, including processing speed, visual scanning, tracking, and motor speed. Participants are given a set of nine symbol-digit pairs and a sequence of symbols. They then have 90 seconds to match as many symbols in the sequence to their corresponding numbers as possible. The score is the number of correct substitutions within the 90 second interval, with a maximum of 110. The results represent a change from baseline to the end of dosing.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | -3.6 | ± 4.3 |
The EDSS is a tool used to measure the severity of multiple sclerosis (MS). The EDSS is based on a combination of scores from eight functional systems (FS), i.e., Muscle weakness, Balance, Coordination and Tremor, Eye Movements, Speech/Swallowing, Unusual Sensations or Numbness, Bowel and Bladder, Eyesight, and Thinking and Memory, and the Disability Status Scale (DSS). The EDSS is a scale that ranges from 0 to 10, with higher scores indicating greater disability. Scores of 1.0 to 4.5 indicate a high degree of ambulatory ability, while scores of 5.0 to 9.5 indicate a loss of ambulatory ability
| Group | Value | 95% CI |
|---|---|---|
| Treatment Group | 0 | 0 – 0 |
Participants underwent 7T MRI during the dosing period and the post-dosing period. The results presented describe the proportion of paramagnetic rim lesions in which the rim was diminished or disappeared during the dosing period (weeks 0-12), during the post-dosing period (weeks 12-24) and during the entire study (weeks 0-24).
| Group | Value | 95% CI |
|---|---|---|
| Weeks 0-12 | 0 | 0 – 0.14 |
| Weeks 12-24 | 0 | 0 – 0 |
| Weeks 0-24 | 0 | 0 – 0.14 |
Paramagnetic rim lesions are multiple sclerosis plaques showing signs of low-grade, ongoing inflammation on MRI. Participants underwent MRI every 4 weeks and we compared the change in size between the participant's paramagnetic rim lesions (PRL+) and non-paramagnetic rim lesions (PRL-). At each time point, the mean group volume of each PRL+ and PRL- was calculated. The results provided include the group means and confidence limits at each time point for PRL+ and PRL- lesion type.
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 168.9 | 114.4 – 252.8 |
| PRL- | 50.7 | 44.8 – 57.7 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 168.4 | 113.6 – 253.0 |
| PRL- | 50.3 | 44.4 – 57.2 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 167.2 | 112.6 – 251.8 |
| PRL- | 49.9 | 44.1 – 56.7 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 175.4 | 117.9 – 264.5 |
| PRL- | 50.7 | 44.8 – 57.7 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 171.3 | 115.9 – 256.4 |
| PRL- | 46.9 | 41.6 – 53.2 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 160.5 | 108.9 – 239.9 |
| PRL- | 47.8 | 42.4 – 54.3 |
Paramagnetic rim lesions are multiple sclerosis plaques showing signs of low-grade, ongoing inflammation on MRI. T1 relaxation time is a measure of brain damage on MRI. Participants underwent MRI every 4 weeks and we compared the change in T1 relaxation time between the participant's paramagnetic rim lesions (PRL+) and non-paramagnetic rim lesions (PRL-) at each time point. The results provided include the group means and confidence limits at each time point for PRL+ and PRL- lesion type.
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1723 | 1612 – 1858 |
| PRL- | 1534 | 1416 – 1697 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1708 | 1599 – 1841 |
| PRL- | 1522 | 1407 – 1680 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1713 | 1603 – 1848 |
| PRL- | 1525 | 1409 – 1683 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1706 | 1597 – 1838 |
| PRL- | 1522 | 1407 – 1679 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1709 | 1600 – 1841 |
| PRL- | 1527 | 1410 – 1687 |
| Group | Value | 95% CI |
|---|---|---|
| PRL+ | 1728 | 1616 – 1865 |
| PRL- | 1525 | 1409 – 1685 |
Time frame: Adverse events were collected for the duration of study participation, i.e., 24 weeks +/- 7 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | All Participants |
|---|---|---|
| Injection site reaction (erythema) | General disorders | — |
| Injection site reaction (pruritus) | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Lymphocyte count decreased | Blood and lymphatic system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Injection site reaction (mild burning) | General disorders | — |
| Injection site reaction | General disorders | — |
| Fatigue | General disorders | — |
| Injection site reaction (stinging) | General disorders | — |
| Injection site reaction (edema) | General disorders | — |
| Injection site reaction (increased bleeding) | General disorders | — |
| Injection site reaction (pain) | General disorders | — |
| Flu-like symptoms | General disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Bronchial infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Platelet count decreased | Investigations | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Metabolism and nutrition disorders other specified; increased appetite | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal and connective tissue disorder - other; left achilles degenerative tendinosis | Musculoskeletal and connective tissue disorders | — |
| Paresthesia | Nervous system disorders | — |
| Extrapyramidal disorder | Nervous system disorders | — |
| Paresthesia (worsening) | Nervous system disorders | — |
| Nervous system disorder - other; hypoesthesia (middle dorsal lateral part of the feet) | Nervous system disorders | — |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
Data from ClinicalTrials.gov NCT04025554 adverse events section.
Background: Multiple sclerosis (MS) is a disease of the central nervous system (CNS). People who have MS may have lesions that form on parts of the CNS, such as the brain. Some of these lesions may be inflamed for a long time. This causes MS to progress. There is no treatment for these lesions. Researchers believe that a drug that decreases inflammation can help. Objective: To see if a drug called anakinra can help clear inflammation in MS brain lesions. Eligibility: People 18 and older with MS and at least one white matter lesion. Design: Participants will be screened with one or more Neuroimmunology Clinic protocols. Participants will have a medical history and physical exam. They will have blood and urine tests. They will have a lumbar puncture. For this, a needle is inserted between the bones in the back, and cerebrospinal fluid is removed. They will also have an MRI of the brain. The MRI scanner is a cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. Participants will repeat the above procedures throughout the study. Participants will get their first dose of anakinra at the clinic. They will administer the rest of the doses themselves, by injection under the skin. Participants will track their daily dosage electronically or in a written drug diary. Participants will have 4 visits while taking the drug. At each visit, sharps boxes and empty vials will be collected. Participants will have 2 follow-up visits after completing treatment. The study will last 28 weeks.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04025554.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing