Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR441566
Balinatunfib · 6 trials · 4 indications
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index \[HAQ-DI\]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 1 is a Full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Maximum plasma concentration observed
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI
| Arm | Type | Description |
|---|---|---|
| SAR441566 dose regimen A | EXPERIMENTAL | Participant will receive dose regimen A of SAR441566 for 12 weeks |
| SAR441566 dose regimen B | EXPERIMENTAL | Participant will receive dose regimen B of SAR441566 for 12 weeks |
| SAR441566 dose regimen C | EXPERIMENTAL | Participant will receive dose regimen C of SAR441566 for 12 weeks |
| SAR441566 dose regimen D | EXPERIMENTAL | Participant will receive dose regimen D of SAR441566 for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Participant will receive SAR441566-matching placebo for 12 weeks |
| SAR441566 dose regimen E | EXPERIMENTAL | Participants received dose regimen E of SAR441566 |
| Balinatunfib Treatment A | EXPERIMENTAL | Participants will receive a single oral dose of balinatunfib. |
| Balinatunfib Treatment B | EXPERIMENTAL | Participants will receive a single oral dose of balinatunfib. |
| Moxifloxacin Treatment C | ACTIVE_COMPARATOR | Participants will receive a single oral dose of moxifloxacin. |
| Placebo Treatment D | PLACEBO_COMPARATOR | Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo. |
| Part I SAR441566 Dose A | EXPERIMENTAL | Participants will receive repeated low dose of SAR441566 for 7.5 days |
| Part I SAR441566 Dose B | EXPERIMENTAL | Participants will receive repeated high dose of SAR441566 for 7.5 days |
| Part I Placebo | PLACEBO_COMPARATOR | Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days |
| Part II Ciprofloxacin | ACTIVE_COMPARATOR | Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days |
| SAR441566 | EXPERIMENTAL | Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle |
| Name | Type | Description |
|---|---|---|
| SAR441566 | DRUG | Tablet |
| Placebo | DRUG | Tablet |
| Balinatunfib | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Moxifloxacin | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Ciprofloxacin | DRUG | Tablet |
Inclusion Criteria: * Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration * Moderate-to-severely active RA, defined as: * persistently active diseas...
Balinatunfib is an investigational small molecule developed by Sanofi for inflammatory bowel disease, including ulcerative colitis. It is in Phase 2 clinical development and has not been approved for any use. Sanofi is studying it in a long-term safety, tolerability and efficacy trial in participants with Crohn's disease or ulcerative colitis.
Balinatunfib is being studied as a treatment for ulcerative colitis, a form of inflammatory bowel disease, and is also being evaluated in Crohn's disease. It is an investigational therapy in Phase 2 development, so it is not available as an approved treatment for ulcerative colitis or any other condition.
Balinatunfib is developed by Sanofi, which trades on the Nasdaq under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the small molecule in inflammatory bowel disease, including ulcerative colitis and Crohn's disease.
Balinatunfib is in Phase 2 clinical development. It is an investigational small molecule and is not FDA approved. Its clinical program includes a Phase 2 long-term safety, tolerability and efficacy study in participants with Crohn's disease or ulcerative colitis.
Balinatunfib has been studied in the SPECIFI-IBD-LTS trial, NCT07222189, a Phase 2 study of long-term safety, tolerability and efficacy in participants with Crohn's disease or ulcerative colitis. The trial was placebo controlled and double blind, enrolled participants across the United States, Argentina, Bulgaria, Chile, China, Czechia and Italy, and is listed as terminated.