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CompletedNCT05508074Updated Oct 10, 2025Results posted

Treatment Combining Riluzole and IFB-088 in Bulbar Amyotrophic Lateral Sclerosis (TRIALS Protocol)

A Phase 2 interventional study of IFB-088 50mg/day and Placebo in Amyotrophic Lateral Sclerosis and ALS, sponsored by InFlectis BioScience. Completed at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.

Sponsored by InFlectis BioScience · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Prospective, international, randomised, double-blind, placebo controlled, multicentre, parallel group study. Patients will be randomised in a 2:1 allocation ratio to receive either IFB-088 + riluzole 100 mg or placebo + riluzole 100 mg. This clinical trial is an exploratory study, designed to show a signal of efficacy of IFB-088 through ALSFRS-R, MITOS and King's College. Respiratory function will be followed through SVC. Biomarkers and quality of life will also be evaluated throughout the study.

Patients will be treated over a 6-month period. After a screening/consent visit, patients will undergo clinic visits at randomisation (V0), at 2 weeks (V1), and at months 1 (V2), 3 (V3) and 6 (V4). One week after V0, the patient will undergo urine analysis (dipstick)and blood sampling for measurement of creatinine

, as well as blood sampling for measurement of creatinine and calculation of eGFR at months 2, 4 and 5. At the V2 visit, in addition to other assessments, patients will undergo blood sampling for PK measurements and urine sampling for crystalluria examination. Blood and urine chemistry, as well as physical examination and vital signs assessment to assess safety will be performed at each visit for safety purpose and crystalluria examination will be repeated at the follow-up visit, performed one month ± one week after V4.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • ALS

Keywords

  • IFB-088
  • Icerguastat
  • ALS
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
  • Neurodegenerative Disease
03

In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.

This study's enrollment of 51 is above the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

InFlectis BioScience is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of probable or definite ALS according to the revised El Escorial criteria [29], with bulbar onset of disease, familial or sporadic form,
  2. Onset of symptoms ≤ 18 months prior to screening, as reported by the patient,
  3. Adult males or females, aged at least 18 years old,
  4. SVC > 60% of predicted value for age and sex,
  5. ALSFRS-R score ≥ 36,
  6. Treatment with riluzole 100 mg/day, at stable dose since at least one month and well tolerated,
  7. Male or female patient of childbearing potential10 who agrees to use highly effective mechanical contraception methods (sexual abstinence, intrauterine device, bilateral tubal occlusion, vasectomised partner) throughout the study, and for 3 months after the end of the treatment,
  8. Patient who read, understood and signed the ICF,
  9. Patient who is willing to adhere to the study visit schedule and is capable to understand and comply with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  1. Known other significant neurological disease(s),
  2. Serious illness(es) or medical condition(s) (e.g. unstable cardiac disease, cancer, hematologic disease, hepatitis or liver failure, renal failure) that is not stabilised or that could require hospitalisation and may jeopardise the participation in the study,
  3. Abnormal renal function at screening defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2,
  4. Abnormal liver function at screening defined as total bilirubin levels >1.5 ULN, and/or AST and/or ALT >3 ULN,
  5. Neutropenia (ANC \<1.5 x 109/L) at screening,
  6. Other causes of neuromuscular weakness,
  7. Non progressive or very rapidly progressing ALS (ALSFRS-R decline from disease onset to randomisation ≤ 0.1 / month or ≥ 1.2 / month)11,
  8. Non-invasive ventilation,
  9. Tracheotomy,
  10. Weight loss ≥ 10% compared to weight at symptoms onset as declared by the patient or BMI \<18 kg/m2 at screening,
  11. Dementia or other severe active psychiatric illness, including suicidal ideation assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS),
  12. Patient with a significant pulmonary disorder not attributed to ALS or who require treatments that might complicate the evaluation of the effect of ALS on respiratory function,
  13. Patient treated by edaravone for ALS,
  14. Patient using unauthorised concomitant treatments, namely moderate or strong inhibitors or inducers of CYP1A2, strong inhibitors or inducers of CYP2D6 or 2C19 and strong inhibitors of OCT2, as listed in Section 6.2. Combined oral contraceptives containing ethinylestradiol are forbidden concomitant medications,
  15. Smoker of > 10 cigarettes per day (e-cigarettes and nicotine patches are permitted),
  16. Known hypersensitivity to any of the ingredients or excipients of the IMPs,
  17. Pregnant, lactating women,
  18. Patient who participated in another trial of investigational drug(s) within 30 days prior to randomisation, or 5 half-lives of the previous investigational product, whichever is longer,
  19. Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    IFB-088 50 mg/day + riluzole 100 mg/day

    The test product, IFB-088, will be administered orally in 50 mg/day dosage consisting of two uptakes of 25 mg each (morning and evening uptakes), as an add-on therapy to riluzole 100 mg. Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition. Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs. Patients will be treated for a period of 6 months (26 weeks).

    Drug: IFB-088 50mg/day · Drug: Riluzole 100mg/day

  • Placebo comparator
    placebo + riluzole 100 mg/day

    The placebo will be administered orally in two uptakes (morning and evening uptakes), as an add-on therapy to riluzole 100 mg. Intervals for dosing should ideally be about 12 hours (± one hour). Tablets will be swallowed with a glass of water 30 minutes before the meal, in fasting condition. Administration of riluzole 100 mg, tablet or suspension, will be at the patient's and/or investigator's choice, as per summary of product characteristics. The daily dose of 100 mg will be taken in two 50 mg doses every 12 hours, at the same time than the IMPs. Patients will be treated for a period of 6 months (26 weeks).

    Drug: Placebo · Drug: Riluzole 100mg/day

Interventions

  • DrugIFB-088 50mg/day

    Tested product

    Also known as: IFB-088, Icerguastat

  • DrugPlacebo

    Placebo

  • DrugRiluzole 100mg/day

    Standard of care treatment, co-administered with tested product (IFB-088 50mg/day) or placebo

    Also known as: Riluzole

06

What researchers measure

Primary outcomes

  1. Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]

    * Incidence, grade and relationship to IFB-088 for treatment emergent AEs (TEAEs), SAEs, and AESIs, * AEs leading to dose interruption or premature discontinuation.

    Time frame: from beginning of IMP intake up to 30 days after stopping the intake, an average of 7 months

Secondary outcomes

  1. Efficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)

    ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised) 12 items, clinician rated including 5 choices from normal to disabled. Maximal score: 48, minimal score: 0 (death)

    Time frame: Efficacy scale from baseline to V3 (3 months) and V4 (6 months).

  2. Efficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)

    ALS\_MITOS (Amyotrophic Lateral Sclerosis Milano-Torino Staging) scale scores the total points of points given in 4 domains (movement, swallowing, communicating, breathing), clinician rated. The ALS8MITOS score is determined by the sum of functional score of 1 for each domain, up to 5, being death. The score may go from 0= no functionnal domain lost, up to 5=death (1 to 4 corresponding to the number of domains lost by the patient).

    Time frame: baseline, V3 (3 months), V4 (6 months)

  3. Efficacy With Scale : King's College Scale (ALS Staging Form)

    King's college Scale (King's ALS staging form), clinician rated, 8 items. 0=best, 5=death

    Time frame: Efficacy scale from baseline to 3 months and 6 months.

  4. Efficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])

    Assessment of respiratory function (slow vital capacity \[SVC\]).

    Time frame: Respiratory function at screening, 3 and 6 months.

  5. Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)

    Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PaCO2 (mmHg), at screening, 3 and 6 months.

    Time frame: Respiratory function at screening, 3 and 6 months.

  6. Efficacy Based on Assessment of Body Composition (Exploratory)

    change of body composition (% of water, muscle, bone in the body) evaluated by bioelectrical impedance

    Time frame: At baseline and 6 months

  7. Pharmacokinetic Parameters (Area Under Curve [AUC])

    Area Under the Curve (AUC (0-12h)) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng.h/mL.

    Time frame: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).

  8. Pharmacokinetic Parameters (Cmax)

    Maximum observed plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng/mL.

    Time frame: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).

  9. Pharmacokinetic Parameters (Tmax)

    Time at which maximum plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139 is measured As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h

    Time frame: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).

  10. Pharmacokinetic Parameters (t1/2)

    Terminal or apparent terminal half-life (t1/2) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h.

    Time frame: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).

  11. Pharmacokinetic Parameters (Clearance)

    IFB-088 Apparent systemic clearance calculation (CL/F) As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L/h.

    Time frame: PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).

  12. Pharmacokinetic Parameters (Vd)

    IFB-088 Apparent volume of distribution (Vd). As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L.

    Time frame: PK parameters will be analysed after 4 weeks of treatment.

  13. Biomarkers (TDP-43)

    Change in TDP-43 plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).

    Time frame: At baseline and 6 months.

  14. Biomarkers (Neurofilament Light Chain)

    Change in neurofilament (NfL) light chain plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).

    Time frame: At baseline and 6 months.

  15. Biomarkers (Inflammation Biomarkers)

    Inflammation biomarkers (interleukin \[IL\]-6, tumour necrosis factor-α \[TNFα\], interferon γ \[IFNγ\], IL-1β, IL-8, IL-10, monocyte chemoattractant protein-1 \[MCP-1\], nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\], vascular endothelial growth factor \[VEGF\]): (concentration of each biomarker in ng/mL, technology Luminex®)).

    Time frame: All assessed at baseline and V4 visit (6 months). Only GDF15, MCP1, BDNF, and TGFb1 also assessed at V3 visit (3 months)

  16. Biomarkers (3-Nitrotyrosine)

    3-Nitrotyrosine (Oxidative stress biomarker): at baseline, 3 and 6 months (concentration in ng/mL, ELISA method).

    Time frame: At baseline, 3 months, and 6 months.

  17. Quality of Life With ALSAQ-40 (ALS Assessment Questionnaire)

    Change in ALS assessment questionnaire (ALSAQ-40). ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire) Quality of Life questionnaire 40 items, patient rated including 5 choices from never to always. best=0, worse=100

    Time frame: QoL will be assessed from baseline to 6 months

  18. Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)

    Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PO2 (mmHg) at screening, 3 and 6 months.

    Time frame: Respiratory function at screening, 3 and 6 months.

  19. Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)

    Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of HCO3 (mEq/L) at screening, 3 and 6 months.

    Time frame: Respiratory function at screening, 3 and 6 months.

  20. Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)

    Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of Oxygen saturation (%) at screening, 3 and 6 months.

    Time frame: Respiratory function at screening, 3 and 6 months.

07

Results

Posted Oct 10, 2025
Limitations and caveats
Assessment of Body Composition (Exploratory) could not be assessed properly due to late availability of the devices. Biomarkers analysis performed by the primary laboratory plant lead to important BLQ data, important CV deviations, requiring cautious interpretation of the results. Additional biomarker analysis were performed in another lab, and were used for post hoc analysis.

Participant flow

Participant flow — Overall Study
MilestonePlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
Started1734
Completed1423
Not completed311
Withdrew: Death25
Withdrew: Withdrawal by subject12
Withdrew: Adverse event01
Withdrew: Physician decision01
Withdrew: Wrongly randomized01
Withdrew: Non-compliance01

Outcome measures

PrimarySafety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]

* Incidence, grade and relationship to IFB-088 for treatment emergent AEs (TEAEs), SAEs, and AESIs, * AEs leading to dose interruption or premature discontinuation.

Time frame:
from beginning of IMP intake up to 30 days after stopping the intake, an average of 7 months
Reported as:
Count of participants · Participants
Safety Assessment of IFB-088 50 mg/Day in Patients With Bulbar-onset ALS. Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]
ParticipantsPlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
TEAE1025
TEAE related to study drug413
Serious TEAE48
Serious TEAE related to study drug02
Fatal TEAE25
Fatal TEAE related to study drug02
Grade 1 TEAE719
Grade 2 TEAE511
Grade > or = 3 TEAE310
Grade > or = 3 TEAE related to study drug03
Grade > or = 3 serious TEAE28
Grade >or = 3 serious TEAE related to study drug02
TEAE leading to temporary discontinuation of study drug11
TEAE leading to definitive discontinuation of study drug03
SecondaryEfficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)

ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised) 12 items, clinician rated including 5 choices from normal to disabled. Maximal score: 48, minimal score: 0 (death)

Time frame:
Efficacy scale from baseline to V3 (3 months) and V4 (6 months).
Reported as:
Mean · score on a scale
Efficacy With Scale : ALSFRS-R (ALS Functional Rating Scale Revised)
score on a scalePlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
ALSFRS-R Baseline43.9 ± 2.142.2 ± 2.7
ALSFRS-R V3 visit (3 months)39.5 ± 5.936.0 ± 8.7
ALSFRS-R V4 visit (6 months)34.7 ± 11.036.1 ± 4.4
Statistical analysis
  • Placebo + Riluzole 100 mg/Day vs IFB-088 50 mg/Day + Riluzole 100 mg/Day · ANCOVA · p = 0.923 · Mean difference (final values): -0.33 · 95% CI -7.27 to 6.60adjusted on baseline ALSFRS-R and treatment.
  • Placebo + Riluzole 100 mg/Day vs IFB-088 50 mg/Day + Riluzole 100 mg/Day · ANCOVA · p = 0.65 (post hoc analysis on the FAS population, adjusted on baseline NfL on top of previous parameters) · Mean difference (final values): 1.5 · 95% CI -5.1 to 8.2
SecondaryEfficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)

ALS\_MITOS (Amyotrophic Lateral Sclerosis Milano-Torino Staging) scale scores the total points of points given in 4 domains (movement, swallowing, communicating, breathing), clinician rated. The ALS8MITOS score is determined by the sum of functional score of 1 for each domain, up to 5, being death. The score may go from 0= no functionnal domain lost, up to 5=death (1 to 4 corresponding to the number of domains lost by the patient).

Time frame:
baseline, V3 (3 months), V4 (6 months)
Reported as:
Mean · score on a scale
Efficacy With Scale : ALS_MITOS (ALS Milano-Torino Staging)
score on a scalePlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
Baseline0 ± 00.1 ± 0.2
V3 visit0.1 ± 0.30.4 ± 0.8
V4 visit0.6 ± 1.20.3 ± 0.6
Statistical analysis
  • Placebo + Riluzole 100 mg/Day vs IFB-088 50 mg/Day + Riluzole 100 mg/Day · binomial exact method · p = 0.398 · Mean difference (final values): -0.118 · 95% CI -0.408 to 0.186
SecondaryEfficacy With Scale : King's College Scale (ALS Staging Form)

King's college Scale (King's ALS staging form), clinician rated, 8 items. 0=best, 5=death

Time frame:
Efficacy scale from baseline to 3 months and 6 months.
Reported as:
Mean · score on a scale
Efficacy With Scale : King's College Scale (ALS Staging Form)
score on a scalePlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
Baseline1.6 ± 0.82.1 ± 0.8
V3 visit2.1 ± 1.22.7 ± 0.9
V4 visit2.8 ± 1.43.0 ± 1.0
Statistical analysis
  • Placebo + Riluzole 100 mg/Day vs IFB-088 50 mg/Day + Riluzole 100 mg/Day · binomial exact method · p = 0.835 · Mean difference (final values): -0.029 · 95% CI -0.326 to 0.271
SecondaryEfficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])

Assessment of respiratory function (slow vital capacity \[SVC\]).

Time frame:
Respiratory function at screening, 3 and 6 months.
Reported as:
Mean · percentage of SVC
Efficacy Based on Assessment of Respiratory Function (Slow Vital Capacity [SVC])
percentage of SVCPlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
Baseline88.5 ± 11.384.7 ± 17.8
V3 visit74.6 ± 21.772.9 ± 18.4
V4 visit67.9 ± 18.469.8 ± 18.3
Statistical analysis
  • Placebo + Riluzole 100 mg/Day vs IFB-088 50 mg/Day + Riluzole 100 mg/Day · ANCOVA · p = 0.481 · Mean difference (final values): 5.31 · 95% CI -9.72 to 20.34
SecondaryEfficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)

Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PaCO2 (mmHg), at screening, 3 and 6 months.

Time frame:
Respiratory function at screening, 3 and 6 months.
Reported as:
Mean · millimeters of Mercury
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PaCO2)
millimeters of MercuryIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
PaCO2 baseline37.8 ± 4.038.5 ± 4.5
PaCO2 V3 Visit38.0 ± 3.939.5 ± 4.3
PaCO2 V4 visit38.7 ± 3.738.0 ± 5.5
SecondaryEfficacy Based on Assessment of Body Composition (Exploratory)

change of body composition (% of water, muscle, bone in the body) evaluated by bioelectrical impedance

Time frame:
At baseline and 6 months

Results for this outcome have not been posted.

SecondaryPharmacokinetic Parameters (Area Under Curve [AUC])

Area Under the Curve (AUC (0-12h)) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng.h/mL.

Time frame:
PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).
Reported as:
Geometric mean · ng.h/mL
Pharmacokinetic Parameters (Area Under Curve [AUC])
ng.h/mLIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
IFB-08863 ± 610 ± 0
IFB-139 (metabolite)69 ± 48.90 ± 0
SecondaryPharmacokinetic Parameters (Cmax)

Maximum observed plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 ng/mL.

Time frame:
PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).
Reported as:
Geometric mean · ng/mL
Pharmacokinetic Parameters (Cmax)
ng/mLIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
IFB-08812 ± 66.40 ± 0
IFB-139 (metabolite)12 ± 45.90 ± 0
SecondaryPharmacokinetic Parameters (Tmax)

Time at which maximum plasma concentration (Cmax) of IFB-088 and its metabolite IFB-139 is measured As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h

Time frame:
PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).
Reported as:
Mean · h
Pharmacokinetic Parameters (Tmax)
hIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
IFB-0881.0 (1.0 to 4.0)0 (0 to 0)
IFB-139 (metabolite)1.0 (1.0 to 4.0)0 (0 to 0)
SecondaryPharmacokinetic Parameters (t1/2)

Terminal or apparent terminal half-life (t1/2) of IFB-088 and its metabolite IFB-139. As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 h.

Time frame:
PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).
Reported as:
Geometric mean · h
Pharmacokinetic Parameters (t1/2)
hIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
IFB-0884.62 ± 40.50 ± 0
IFB-139 (metabolite)7.9 ± 35.40 ± 0
SecondaryPharmacokinetic Parameters (Clearance)

IFB-088 Apparent systemic clearance calculation (CL/F) As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L/h.

Time frame:
PK parameters will be analysed after 4 weeks of treatment. Blood samples were collected at V2 (5 samples/patient: pre-IMP dose, and at one, 2, 4 and 6 hours post dose).
Reported as:
Geometric mean · L/h
Pharmacokinetic Parameters (Clearance)
L/hIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
Pharmacokinetic Parameters (Clearance)580 ± 73.00 ± 0
SecondaryPharmacokinetic Parameters (Vd)

IFB-088 Apparent volume of distribution (Vd). As study was double blinded, the analysis was done on all the patients, either receiving IFB-088 or placebo. Dosage of IFB-088 in patients under placebo was equal to 0 L.

Time frame:
PK parameters will be analysed after 4 weeks of treatment.
Reported as:
Geometric mean · L
Pharmacokinetic Parameters (Vd)
LIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
Pharmacokinetic Parameters (Vd)3722 ± 57.90 ± 0
SecondaryBiomarkers (TDP-43)

Change in TDP-43 plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).

Time frame:
At baseline and 6 months.

Results for this outcome have not been posted.

SecondaryBiomarkers (Neurofilament Light Chain)

Change in neurofilament (NfL) light chain plasmatic concentration from baseline to 6 months, compared to placebo (concentration in pg/mL, technology Simoa®).

Time frame:
At baseline and 6 months.
Reported as:
Geometric mean · pg/mL
Biomarkers (Neurofilament Light Chain)
pg/mLIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
Baseline86.57 (74.60 to 100.45)65.29 (50.73 to 84.02)
V4 visit92.91 (76.51 to 112.34)76.19 (61.95 to 93.70)
Statistical analysis
  • IFB-088 50 mg/Day + Riluzole 100 mg/Day vs Placebo + Riluzole 100 mg/Day · ANCOVA · p = 0.609 · Adjusted geometric mean ratio: 1.04 · 95% CI 0.89 to 1.21
SecondaryBiomarkers (Inflammation Biomarkers)

Inflammation biomarkers (interleukin \[IL\]-6, tumour necrosis factor-α \[TNFα\], interferon γ \[IFNγ\], IL-1β, IL-8, IL-10, monocyte chemoattractant protein-1 \[MCP-1\], nerve growth factor \[NGF\], brain-derived neurotrophic factor \[BDNF\], vascular endothelial growth factor \[VEGF\]): (concentration of each biomarker in ng/mL, technology Luminex®)).

Time frame:
All assessed at baseline and V4 visit (6 months). Only GDF15, MCP1, BDNF, and TGFb1 also assessed at V3 visit (3 months)
Reported as:
Geometric mean · ng/mL
Biomarkers (Inflammation Biomarkers)
ng/mLIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
GDF15 baseline704.26 (565.60 to 876.93)580.31 (437.58 to 769.61)
GDF15 V3 visit711.31 (556.90 to 908.54)572.30 (421.00 to 777.98)
GDF15 V4 visit704.90 (541.44 to 917.70)580.13 (445.10 to 756.11)
MCP1 baseline168.00 (146.12 to 193.16)149.61 (117.08 to 191.17)
MCP1 V3 visit163.47 (137.89 to 193.79)131.92 (107.57 to 161.78)
MCP1 V4 visit171.21 (145.78 to 201.06)127.53 (100.29 to 162.18)
BDNF baseline2348.36 (1768.30 to 3118.70)2717.82 (1687.30 to 4377.72)
BDNF V3 visit1892.51 (1364.30 to 2625.23)2277.30 (1221.31 to 4246.35)
BDNF V4 visit1777.28 (1208.59 to 2613.55)2717.49 (1673.06 to 4413.92)
TGFb1 baseline30524.88 (24598.01 to 37879.82)34174.62 (23139.56 to 50472.23)
TGFb1 V3 visit25955.30 (20552.48 to 32778.39)28333.44 (18658.68 to 43024.70)
TGFb1 V4 visit20906.55 (15906.89 to 27477.63)37702.08 (26739.69 to 53158.68)
8-OxoDG baseline203.01 (173.78 to 237.15)175.29 (142.60 to 215.49)
8-OxoDG V4 visit220.68 (187.12 to 260.27)215.11 (159.73 to 289.69)
FGF21 baseline302.11 (187.86 to 485.85)274.81 (144.29 to 523.40)
FGF21 V4 visit230.51 (129.51 to 410.28)298.73 (163.68 to 545.22)
NGFR/p75ECD baseline5143.46 (4135.27 to 6397.47)4281.16 (2994.38 to 6120.91)
NGFR/p75ECD V4 visit6675.13 (5401.43 to 8249.19)6108.71 (4569.22 to 8166.90)
IL-6 baselineNA (NA to NA)NA (NA to NA)
IL-6 V4 visitNA (NA to NA)NA (NA to NA)
TNFa baselineNA (NA to NA)NA (NA to NA)
TNFa V4 visitNA (NA to NA)NA (NA to NA)
IFNg baselineNA (NA to NA)NA (NA to NA)
IFNg V4 visitNA (NA to NA)NA (NA to NA)
IL1b baselineNA (NA to NA)NA (NA to NA)
IL1b V4 visitNA (NA to NA)NA (NA to NA)
IL8 baselineNA (NA to NA)NA (NA to NA)
IL8 V4 visitNA (NA to NA)NA (NA to NA)
IL10 baselineNA (NA to NA)NA (NA to NA)
IL10 V4 visitNA (NA to NA)NA (NA to NA)
SecondaryBiomarkers (3-Nitrotyrosine)

3-Nitrotyrosine (Oxidative stress biomarker): at baseline, 3 and 6 months (concentration in ng/mL, ELISA method).

Time frame:
At baseline, 3 months, and 6 months.

Results for this outcome have not been posted.

SecondaryQuality of Life With ALSAQ-40 (ALS Assessment Questionnaire)

Change in ALS assessment questionnaire (ALSAQ-40). ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire) Quality of Life questionnaire 40 items, patient rated including 5 choices from never to always. best=0, worse=100

Time frame:
QoL will be assessed from baseline to 6 months
Reported as:
Mean · score on a scale
Quality of Life With ALSAQ-40 (ALS Assessment Questionnaire)
score on a scaleIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
Baseline40.7 ± 20.539.5 ± 22.3
V4 visit67.1 ± 31.361.4 ± 27.5
SecondaryEfficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)

Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of PO2 (mmHg) at screening, 3 and 6 months.

Time frame:
Respiratory function at screening, 3 and 6 months.
Reported as:
Mean · millimeters of Mercury
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), PO2 (mmHg)
millimeters of MercuryIFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
PaO2 baseline88.8 ± 16.897.5 ± 25.8
PaO2 V3 Visit97.4 ± 24.589.1 ± 14.1
PaO2 V4 Visit91.6 ± 12.693.3 ± 27.6
SecondaryEfficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)

Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of HCO3 (mEq/L) at screening, 3 and 6 months.

Time frame:
Respiratory function at screening, 3 and 6 months.
Reported as:
Mean · mEq/L (HCO3)
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), HCO3 (mEq/L)
mEq/L (HCO3)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
HCO3 baseline24.7 ± 1.924.8 ± 1.9
HCO3 V3 visit24.8 ± 2.224.8 ± 2.7
HCO3 V4 visit25.5 ± 2.624.6 ± 3.5
SecondaryEfficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)

Assessment of respiratory function (Arterial Blood Gases \[ABG\]): description of Oxygen saturation (%) at screening, 3 and 6 months.

Time frame:
Respiratory function at screening, 3 and 6 months.
Reported as:
Mean · % (O2 sat)
Efficacy Based on Assessment of Respiratory Function (Arterial Blood Gases [ABG]), Oxygen Saturation (%)
% (O2 sat)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/Day
O2 saturation baseline96 ± 2.596.9 ± 1.7
O2 saturation V3 visit95.2 ± 6.096.3 ± 2.1
O2 stauration V4 visit96.7 ± 1.796.6 ± 2.2

Adverse events

Collected over 7 months, from inclusion to last patient visit, one month after 6 months treatment ending. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Riluzole 100 mg/Day2/17 (11.8%)4/17 (23.5%)10/17 (58.8%)
IFB-088 50 mg/Day + Riluzole 100 mg/Day5/34 (14.7%)8/34 (23.5%)25/34 (73.5%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventPlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
COVID 19Infections and infestations1/170/34
Pneumonia aspirationInfections and infestations1/170/34
Pneumonia viralInfections and infestations1/170/34
Respiratory distressRespiratory, thoracic and mediastinal disorders0/172/34
Respiratory failureRespiratory, thoracic and mediastinal disorders1/171/34
Device related sepsisInfections and infestations0/171/34
Respiratory tract infectionInfections and infestations0/171/34
Lung disorderRespiratory, thoracic and mediastinal disorders0/171/34
cardiac arrestCardiac disorders0/171/34
cardio-respiratory arrestCardiac disorders0/171/34
Most frequent other events
Showing 10 of 64
Most frequent other events
EventPlacebo + Riluzole 100 mg/DayIFB-088 50 mg/Day + Riluzole 100 mg/Day
fallInjury, poisoning and procedural complications0/178/34
gastrostomySurgical and medical procedures2/171/34
respiratory failureRespiratory, thoracic and mediastinal disorders2/171/34
COVID-19Infections and infestations2/173/34
Oral fungal infectionInfections and infestations2/171/34
NauseaGastrointestinal disorders1/173/34
DiarrhoeaGastrointestinal disorders0/173/34
gastrooesophageal reflux diseaseGastrointestinal disorders1/172/34
abdominal painGastrointestinal disorders0/172/34
dysphagiaGastrointestinal disorders0/172/34

Baseline characteristics

Age, Continuous
Age, Continuous(years)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
Mean62.4 ± 9.661.1 ± 11.062.0 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
Female16622
Male181129
Race (NIH/OMB)
Race (NIH/OMB)(Participants)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White341751
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
Italy14923
France20828
BMI
BMI(kg/m^2)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
Median24.49 ± 3.6023.88 ± 4.1224.29 ± 3.75
Tobacco smoking, n (%)
Tobacco smoking, n (%)(Participants)IFB-088 50 mg/Day + Riluzole 100 mg/DayPlacebo + Riluzole 100 mg/DayTotal
Missing data011
No301646
Yes404
08

Study locations

9 sites
  • Hôpital Neurologique Pierre Wertheimer
    Bron, 69677, France
  • APHM Hôpital La Timone Adultes SCE Maladies Neuromusculaires / SLA
    Marseille, 13385, France
  • CHU de Nantes - Hôpital Laennec
    Nantes, 44093, France
  • CHU de Toulouse - Hôpital Pierre-Paul Riquet
    Toulouse, 31059, France
  • CHU Bretonneau
    Tours, 37044, France
  • Ospedale Civile Sant'Agostino Estense
    Baggiovara, 41126, Italy
  • Centro Clinico NeMO per le Malattie Neuromuscolari
    Gussago, 25064, Italy
  • IRCSS Istituto Neurologico Carlo Besta
    Milan, 20133, Italy
  • Sant'Andrea Hospital Unit of Neuromuscular Disorders
    Roma, 00189, Italy
09

References and documents

Study documents

  • Study protocol · Apr 8, 2024
  • Statistical analysis plan · Nov 12, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05508074
Lead sponsor
InFlectis BioScience
Responsible party
Sponsor
First posted
Aug 19, 2022
Start date
Dec 2, 2022
Primary completion
Nov 14, 2024
Completion
Jan 20, 2025
Results posted
Oct 10, 2025
Last update
Oct 10, 2025

Study contacts

Shahram Attarian, Pr
principal investigator · Assistance Publique Hôpitaux de Marseille (APHM) Hospital La Timone Adultes, France
Giuseppe Lauria, Pr
principal investigator · IRCCS Carlo Besta Institute of Milan, Italy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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