A Phase 3 interventional study of Fingolimod and Placebo Comparator in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Novartis Pharmaceuticals. Completed at 67 sites in 15 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-30.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States — 20 open to participants now, 25 under way, 10 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · United States.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, this one is the 15th largest by enrollment of the 42 interventional ones that give a count, is one of 2 that started in 2012, is one of 15 in phase 3, and was the 9th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →20 of the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States are open now. Recruiting first, the newest first:
Kedrion S.p.A. · Sites in United States
Ages 18+
Kite, A Gilead Company · Sites in United States, Australia, Canada
Ages 18–75
Grifols Therapeutics LLC · Sites in United States, Czechia, Poland and 1 more country
Ages 18+
argenx · Sites in United States, Argentina, Austria and 22 more countries
Ages 18+
argenx · Sites in United States, Argentina, Australia and 28 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 17 · Phase 3 16 · Phase 4 2
First in 1990; this study’s year is marked. 2 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 106 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 74 across the 42 interventional studies, 120 across the 12 observational. Of the 28 that completed or were terminated, 14 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 1 study filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
10 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT06680037TG Therapeutics, Inc.A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders | 2026-12-01 |
Add all 10 to your calendar (.ics) → With an account.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.
This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group study in patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo.
The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a Follow-up Period after discontinuation of study drug treatment. Patients who complete the study will have an option to enter an extension.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received Fingolimod 0.5 mg orally once daily.
Drug: Fingolimod
Participants received matching placebo to Fingolimod orally once daily.
Drug: Placebo Comparator
Fingolimod 0.5 mg capsules
Matching placebo capsules
Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale
Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.
Time frame: Month 12
Change From Baseline for Grip Strength, Dominant Hand
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time frame: baseline, Month 6, Month 12
Change From Baseline for Grip Strength, Non-dominant Hand
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time frame: baseline, Month 6, Month 12
Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.
Time frame: baseline, Month 6, Month 12
| Milestone | Fingolimod (FTY720) | Placebo |
|---|---|---|
| Started | 54 | 52 |
| Completed | 34 | 41 |
| Not completed | 20 | 11 |
| Withdrew: Administrative problems | 1 | 0 |
| Withdrew: Protocol deviation | 0 | 2 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Withdrawal by subject | 5 | 1 |
| Withdrew: Lack of efficacy | 12 | 8 |
Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.
| Days | Fingolimod (FTY720) | Placebo |
|---|---|---|
| Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale | 721.0 (159.0 to NA) | 540.0 (183.0 to NA) |
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
| kPa | Fingolimod (FTY720) | Placebo |
|---|---|---|
| Month 6 | -2.6 (-8.09 to 2.80) | -3.8 (-9.37 to 1.70) |
| Month 12 | -0.8 (-6.47 to 4.96) | -3.9 (-9.68 to 1.94) |
Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
| kPa | Fingolimod (FTY720) | Placebo |
|---|---|---|
| Month 6 | -2.7 (-8.13 to 2.66) | -6.1 (-11.59 to -0.66) |
| Month 12 | -1.2 (-6.69 to 4.37) | -5.0 (-10.57 to 0.64) |
This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.
| score on a scale | Fingolimod (FTY720) | Placebo |
|---|---|---|
| Month 6 | -6.4 (-9.57 to -3.15) | -5.5 (-8.89 to -2.21) |
| Month 12 | -5.7 (-9.07 to -2.37) | -5.1 (-8.54 to -1.57) |
Non-serious events are listed at a 0.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fingolimod (FTY720) | — | 9/54 (16.7%) | 40/54 (74.1%) |
| Placebo | — | 4/52 (7.7%) | 42/52 (80.8%) |
| Overall Participants | — | 13/106 (12.3%) | 82/106 (77.4%) |
| Event | Fingolimod (FTY720) | Placebo | Overall Participants |
|---|---|---|---|
| Chronic inflammatory demyelinating polyradiculoneuropathyNervous system disorders | 2/54 | 1/52 | 3/106 |
| Ankle fractureInjury, poisoning and procedural complications | 0/54 | 1/52 | 1/106 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/54 | 1/52 | 1/106 |
| Cauda equina syndromeNervous system disorders | 0/54 | 1/52 | 1/106 |
| NephrolithiasisRenal and urinary disorders | 0/54 | 1/52 | 1/106 |
| Oedema peripheralGeneral disorders | 1/54 | 0/52 | 1/106 |
| Abdominal sepsisInfections and infestations | 1/54 | 0/52 | 1/106 |
| CellulitisInfections and infestations | 1/54 | 0/52 | 1/106 |
| BursitisMusculoskeletal and connective tissue disorders | 1/54 | 0/52 | 1/106 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/54 | 0/52 | 1/106 |
| Event | Fingolimod (FTY720) | Placebo | Overall Participants |
|---|---|---|---|
| HeadacheNervous system disorders | 12/54 | 8/52 | 20/106 |
| HypertensionVascular disorders | 10/54 | 1/52 | 11/106 |
| NasopharyngitisInfections and infestations | 6/54 | 7/52 | 13/106 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 7/54 | 3/52 | 10/106 |
| NauseaGastrointestinal disorders | 2/54 | 6/52 | 8/106 |
| FatigueGeneral disorders | 4/54 | 6/52 | 10/106 |
| ParaesthesiaNervous system disorders | 5/54 | 0/52 | 5/106 |
| InsomniaPsychiatric disorders | 1/54 | 4/52 | 5/106 |
| FallInjury, poisoning and procedural complications | 4/54 | 1/52 | 5/106 |
| Back painMusculoskeletal and connective tissue disorders | 4/54 | 3/52 | 7/106 |
| Age, Continuous(Years) | Fingolimod (FTY720) | Placebo | Total |
|---|---|---|---|
| Mean | 54.3 ± 13.32 | 54.6 ± 11.68 | 54.5 ± 12.48 |
| Sex: Female, Male(Participants) | Fingolimod (FTY720) | Placebo | Total |
|---|---|---|---|
| Female | 17 | 22 | 39 |
| Male | 37 | 30 | 67 |
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Dec 2012 to primary completion in Sep 2016, 44 months.
Results were first posted in Sep 2017, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Fingolimod
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →