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Phase 2b study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.
This phase 2b study will evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in improving Modified Mayo Score (MMS) in patients with moderate to severe Ulcerative Colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-α] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment .
Eligible patients will be randomized into 4 parallel intervention/treatment groups: 100mg q.d of ABX464, 50mg q.d of ABX464, 25mg q.d of ABX464, or matching placebo and will be treated for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 100 mg | Experimental | ABX464 100 mg was administered orally (capsules) once daily for 16 weeks |
|
| ABX464 50 mg | Experimental | ABX464 50 mg was administered orally (capsules) once daily for 16 weeks |
|
| ABX464 25 mg | Experimental | ABX464 25 mg was administered orally (capsules) once daily for 16 weeks |
|
| Matching Placebo | Placebo Comparator | Matching placebo was administered orally (capsules) once daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 100 mg | Drug | ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From Baseline in Modified Mayo Score (MMS) at Week 8 | Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction From Baseline in MMS at Week 16 | Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. |
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Inclusion Criteria:
Men or women age 18 - 75 years;
Diagnosis of moderate to severe active UC (including ulcerative proctitis if proximal extension of disease occurs beyond 10 cm) confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by Modified Mayo Score (MMS) of 5 to 9 inclusive (on a scale of 0-9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
Patients having either a documented inadequate response, no response, a loss of response, or an intolerance (defined as the occurrence of at least one Adverse Reaction leading to treatment discontinuation) to either immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor [TNF] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. Inadequate response, no response, loss of response is defined as:
i. Active disease or relapse in spite of thiopurines or methotrexate given at an appropriate dose for at least 3 months (i.e. azathioprine 2-2.5 mg/kg/day or mercaptopurine 1-1.5 mg/kg/day in the absence of leukopenia), and/or ii. Active disease despite corticosteroids treatment (prednisolone up to 0.75 mg/kg/day) over a period of 4 Weeks, and/or iii. Active disease or relapse in spite of adequate treatment (as defined in the SmPC) with tumor necrosis factor [TNF] inhibitors or vedolizumab, and/or iv. Active disease or relapse in spite of adequate treatment with JAK inhibitors over a period of at least 6 Weeks.
Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (≤20 mg/day) or on beclomethasone diproprionate (≤5mg/day) or on budesonide MMX (≤9 mg/day) for at least 2 Weeks prior to the screening visit;
Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;
Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;
Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
Patients on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii) must be on stable doses for at least 2 Weeks prior to the screening visit;
Patients on antidiarrheals (e.g., loperamide, diphenoxylate with atropine) must be on stable doses for at least 2 Weeks prior to the screening visit;
Patients who have received tumor necrosis factor [TNF] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight;
Patients with surveillance colonoscopy defined as per ECCO guidelines;
Patients with the following hematological and biochemical laboratory parameters obtained at screening:
i. Hemoglobin > 9.0 g dL-1; ii. Absolute neutrophil count ≥ 750 mm-3; iii. Platelets ≥ 100,000 mm-3; iv. Total serum creatinine ≤ 1.3 x ULN (upper limit of normal); v. Creatinine clearance > 90 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline; vi. Total serum bilirubin < 1.5 x ULN; vii. Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN;
Patients are able and willing to comply with study visits and procedures as per protocol;
Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed;
Patients should be affiliated to a social security regimen (for French sites only);
Females and males receiving the study treatment (potentially in combination with immunosuppressant) and their partners must agree to use a highly effective contraceptive method during the study and for 6 months after end of study or early termination. Contraception should be in place at least 2 Weeks prior to study participation. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with an infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male participants should use condoms and not donate sperm as long as contraception is required.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Séverine VERMEIRE, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Health System | San Diego | California | 92103 | United States | ||
| Atlanta Center for Gastroenterology, P.C |
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Randomization to treatment arms was stratified by previous exposure/non-exposure to biologics and JAK inhibitors treatment use and US/non-US sites.
A total of 355 patients consented to participate, 254 patients were randomized. A total of 253 patients were treated, 222 patients completed study treatment. 32 patients discontinued and 1 patient was randomized but did not receive study drug. One further patient was excluded from the Full Analysis Set (FAS) due to noncompliance with inclusion/exclusion criteria. A total of 252 patients were included in the FAS (64: ABX464 100mg q.d, 63: ABX464 50mg q.d, 61: ABX464 25mg q.d and 64: placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | ABX464 100 mg | ABX464 100 mg was administered orally (two capsules of ABX464 50 mg) once daily for 16 weeks |
| FG001 | ABX464 50 mg | ABX464 50 mg was administered orally (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2020 | May 16, 2024 |
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Randomized, double blind, placebo controlled, parallel groups
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| ABX464 50 mg | Drug | ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks |
|
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| ABX464 25 mg | Drug | ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
|
|
| Placebo | Drug | Two capsules of placebo once daily for 16 weeks |
|
|
| Week 16 |
| Number of Participants in Clinical Remission Per MMS at Week 8 | Number of participants who achieved clinical remission per Modified Mayo Score at Week 8 MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability) | Week 8 |
| Number of Participants in Clinical Remission Per MMS at Week 16 | Number of participants who achieved clinical remission per Modified Mayo Score at Week 16 MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability) | Week 16 |
| Number of Participants With Clinical Response at Week 8 | Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point. | Week 8 |
| Number of Participants With Clinical Response at Week 16 | Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point. | Week 16 |
| Number of Participants With Endoscopic Improvement at Week 8 | Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher endoscopic score indicates more severe disease. | Week 8 |
| Number of Participants With Endoscopic Improvement at Week 16 | Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher endoscopic score indicates more severe disease. | Week 16 |
| Number of Participants With Mucosal Healing at Week 8 | Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score <2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity. | Week 8 |
| Number of Participants With Mucosal Healing at Week 16 | Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score <2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity. | Week 16 |
| Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1) | Participants recorded stool frequency using an electronic subject diary on a daily basis. The stool frequency subscore (SFS) ranges from 0 to 3 according to the following scale: Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal Decreasing score indicates improvement. | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
| Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline | Participants recorded rectal bleeding in an electronic subject diary on a daily basis. Rectal bleeding score (RBS) is taken as the worst subscore of the three most recent scores within 7 days prior to the visit. The rectal bleeding subscore ranges from 0 to 3 according to the following scale: Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding. | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
| Partial Modified Mayo Score Change From Baseline | Partial Modified Mayo Score (pMMS) Change from baseline The pMMS is a composite score of UC disease activity based on the following 2 subscores:
The overall pMMS score ranges from 0 to 6 with higher scores representing more severe disease. | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
| Number of Participants With Reduction Relative to Baseline in Fecal Calprotectin at Weeks 8 and 16 | Fecal Calprotectin (FC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. FC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. Outcome will be measured based on a reduction in FC relative to baseline values. | Week 8 and Week 16 |
| Number of Participants With Reduction Relative to Baseline in C Reactive Protein at Weeks 8 and 16 | CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria. Outcome will be measured based on a reduction in CRP relative to baseline values. | Week 8 and Week 16 |
| miRNA-124 Expression (Copy Number) in Whole Blood at Week 8 and Week 16 | Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at Week 8 and Week 16 using droplet digital PCR technology (ddPCR) on whole blood samples. "0" in the placebo column means "no signal", so BLQ (Below the level of quantification). | Week 8 and Week 16 |
| IL-6 Serum Concentrations | Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)*100 | Day 1 |
| Number of Participants With Endoscopic Remission at Week 8 | Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher score represents more severe disease. | Week 8 |
| Number of Participants With Endoscopic Remission at Week 16 | Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher score represents more severe disease. | Week 16 |
| IL-10 Serum Concentrations | Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)*100 | Day 1 |
| IL-1B Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)*100 | Day 1 |
| TNFα Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)*100 | Day 1 |
| Change From Baseline in Infiltrate/Histopathology Using Robarts Histopathology Index (RHI) at Week 8 and Week 16 | Infiltrate/Histopathology (Rectal/Sigmoidal Biopsies) using the Robarts Histopathology Index (RHI) Week 8 and Week 16 biopsies will be compared to biopsies at baseline to assess the disease evolution at a tissue level, based on the Robarts Histological Index. The score ranges from 0 (no disease activity) to 33 (severe disease activity) is based on evaluation of 4 parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium and erosion and ulceration. A higher score indicates more severe disease. | Week 8 and Week 16 |
| Change From Baseline in Infiltrate/Histopathology - Geboes Score at Week 8 and Week 16 | The Geboes score is composed of 6 major grades that assess different aspects of the biopsy findings, with each grade having its own score range:
Subscales are summed across all 6 grades, final total score between 0 and 18 :
| Week 8 and Week 16 |
| IL-6 Serum Concentrations | Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)*100 | Day 8, Day 29, Day 57, and Day 113 |
| IL-10 Serum Concentrations | Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)*100 | Day 8, Day 29, Week 8 and Week 16 |
| IL-1B Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)*100 | Day 8, Day 29, Day 57 and Day 113 |
| TNFα Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)*100 | Day 8, Day 29, Day 57 and Day 113 |
| Decatur |
| Georgia |
| 30033 |
| United States |
| Central Texas Clinical Research, LLC | Austin | Texas | 78705 | United States |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78212 | United States |
| Medizinische Universität Innsbruck | Innsbruck | Austria |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | Austria |
| Ordensklinikum Linz GmbH - Barmherzige Schwestern | Linz | Austria |
| AKH - Medizinische Universität Wien | Vienna | Austria |
| Gomel Regional Clinical Hospital | Homyel | Belarus |
| Minsk city diagnostic center | Minsk | Belarus |
| Regional Clinical Hospital | Minsk | Belarus |
| Vitebsk Regional Clinical Hospital | Vitebsk | Belarus |
| Vitebsk regoinal clinical specialized center | Vitebsk | Belarus |
| AZ Sint-Lucas | Bruges | Belgium |
| C. H. U. St-Pierre | Brussels | Belgium |
| UZA | Edegem | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| UZ Leuven | Leuven | Belgium |
| Brandon Medical Arts Clinic | Brandon | Canada |
| South Edmonton Gastroenterology | Edmonton | Canada |
| LHSC - Victoria Hospital | London | Canada |
| The Ottawa Hospital - General Campus | Ottawa | Canada |
| Allen Whey Khye Lim Professional Corporation | Saskatoon | Canada |
| Mount Sinai Hospital | Toronto | Canada |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia |
| Hepato-Gastroenterologie HK s.r.o. | Hradec Králové | Czechia |
| MUDr. GREGAR s.r.o. | Olomouc | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Kunčice | Czechia |
| Nemocnice Na Bulovce | Prague | Czechia |
| Thomayerova nemocnice | Prague | Czechia |
| Nemocnice Slany | Slaný | Czechia |
| CHU Amiens - Hopital Sud | Amiens | France |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | France |
| CHU Clermont Ferrand - Hôpital d'Estaing | Clermont-Ferrand | France |
| Hôpital Beaujon | Clichy | France |
| CHU de Grenoble - Hôpital Nord | Grenoble | France |
| Centre Hospitalier Départemental Les Oudairies | La Roche-sur-Yon | France |
| CHU Lille - Hôpital Claude Huriez | Lille | France |
| Hôpital Nord - CHU Marseille | Marseille | France |
| Hopital Saint Eloi | Montpellier | France |
| CHU Nantes - Hôtel Dieu | Nantes | France |
| CHU Nice - Hôpital de l'Archet 2 | Nice | France |
| CHU Reims - Hôpital Robert Debré | Reims | France |
| CHU Rennes - Hôpital Pontchaillou | Rennes | France |
| CHU de Rouen - Hôpital Charles Nicolle | Rouen | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | France |
| CHU Strasbourg - Hôpital Hautepierre | Strasbourg | France |
| Hopital Rangueil | Toulouse | France |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | France |
| Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | Germany |
| Florence-Nightingale-Krankenhaus-Diakonie Kaiserswerth | Düsseldorf | Germany |
| Klinikum der Johann Wolfgang Goethe-Universitaet | Frankfurt | Germany |
| Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt | Halle | Germany |
| Universitaetsklinikum Halle (Saale) | Halle | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Johanna-Etienne-Krankenhaus | Neuss | Germany |
| Tumorzentrum Nordthueringen MVZ GmbH | Nordhausen | Germany |
| Dr. Tasso Bieler | Riesa | Germany |
| Universitaetsklinikum Ulm | Ulm | Germany |
| DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | Hungary |
| Obudai Egeszsegugyi Centrum Kft. | Budapest | Hungary |
| Pannonia Maganorvosi Centrum | Budapest | Hungary |
| Semmelweis Egyetem | Budapest | Hungary |
| Debreceni Egyetem | Debrecen | Hungary |
| Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont | Debrecen | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | Hungary |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | Italy |
| Fondazione Poliambulanza Istituto Ospedaliero | Brescia | Italy |
| Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | Italy |
| I.R.C.C.S Policlinico San Donato | Milan | Italy |
| Ospedale Sacro Cuore Don Calabria | Negrar | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo | Italy |
| Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) | Pisa | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Szpital Uniwersytecki nr 2 im.dr J. Biziela | Bydgoszcz | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Centrum Medyczne Plejady | Krakow | Poland |
| Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz | Poland |
| Wojskowy Szpital Kliniczny w Lublinie | Lublin | Poland |
| Trialmed CRS | Piotrkow Trybunalski | Poland |
| Centrum Medyczne Grunwald | Poznan | Poland |
| KO-MED Centra Kliniczne Pulawy | Puławy | Poland |
| Gabinet Lekarski Bartosz Korczowski | Rzeszów | Poland |
| Centrum Zdrowia MDM | Warsaw | Poland |
| Nzoz Vivamed | Warsaw | Poland |
| Centrum Zdrowia Tuchow Sp. z o.o. | Wierzchosławice | Poland |
| Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland |
| Centrum Medyczne Oporow | Wroclaw | Poland |
| LexMedica | Wroclaw | Poland |
| Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade | Serbia |
| Clinical Center Bezanijska Kosa | Belgrade | Serbia |
| Clinical Center Zvezdara | Belgrade | Serbia |
| General Hospital Uzice | Užice | Serbia |
| General Hospital "Djordje Joanovic" | Zrenjanin | Serbia |
| Alian s.r.o. | Bardejov | Slovakia |
| Cliniq s.r.o. | Bratislava | Slovakia |
| Gastromedic, s.r.o. | Nové Zámky | Slovakia |
| Gastro I, s.r.o. | Prešov | Slovakia |
| Accout Center s.r.o. | Šahy | Slovakia |
| Endomed, s.r.o. | Vranov nad Topľou | Slovakia |
| General Hospital Celje | Celje | Slovenia |
| University Medical Centre Maribor | Maribor | Slovenia |
| General Hospital Murska Sobota | Murska Sobota | Slovenia |
| Centro Médico Teknon | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Spain |
| Hospital Quironsalud Malaga | Málaga | Spain |
| CNE Cherkasy Regional Hospital of Cherkasy Regional Council | Cherkasy | Ukraine |
| I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | Ukraine |
| Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU | Ivano-Frankivsk | Ukraine |
| CHI Kharkiv City Clinical Hospital #13 | Kharkiv | Ukraine |
| CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | Ukraine |
| Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | Ukraine |
| CI Kherson CCH | Kherson | Ukraine |
| Khmelnytska Regional Hospital | Khmelnytskyi | Ukraine |
| Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital | Kyiv | Ukraine |
| Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU | Lviv | Ukraine |
| Ternopil University Hospital | Ternopil | Ukraine |
| A. Novak Transcarpathian Regional Clinical Hospital | Uzhhorod | Ukraine |
| CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia | Ukraine |
| M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU | Vinnytsia | Ukraine |
| MCIC MC LLC Health Clinic | Vinnytsia | Ukraine |
| CI City Clinical Hospital #6 Dept of Gastroenterology | Zaporizhzhia | Ukraine |
| CNCE "City Hospital 9" Zaporizhzhia CC | Zaporizhzhia | Ukraine |
| Fairfield General Hospital | Bury | United Kingdom |
| Guy's Hospital | London | United Kingdom |
| University College London Hospitals | London | United Kingdom |
| Nottingham University Hospitals Queen's Medical Centre | Nottingham | United Kingdom |
| FG002 | ABX464 25 mg | ABX464 25 mg was administered orally (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| FG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
| Treated |
|
| Full Analysis Set |
|
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABX464 100 mg | ABX464 100 mg: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks |
| BG001 | ABX464 50 mg | ABX464 50 mg: ABX464 50mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks |
| BG002 | ABX464 25mg | ABX464 25 mg: ABX464 25mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| BG003 | Matching Placebo | Matching placebo will be administered orally (capsules) once daily for 16 weeks Placebo: Two capsules of placebo once daily for 16 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Modified Mayo Score (MMS) | The MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction From Baseline in Modified Mayo Score (MMS) at Week 8 | Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Least Squares Mean | 95% Confidence Interval | Score | Week 8 |
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| Secondary | Reduction From Baseline in MMS at Week 16 | Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Least Squares Mean | 95% Confidence Interval | Score | Week 16 |
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| Secondary | Number of Participants in Clinical Remission Per MMS at Week 8 | Number of participants who achieved clinical remission per Modified Mayo Score at Week 8 MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability) | Full analysis set | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants in Clinical Remission Per MMS at Week 16 | Number of participants who achieved clinical remission per Modified Mayo Score at Week 16 MMS is a composite score of UC disease activity based on the following 3 subscores:
The overall MMS ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1 (modified to exclude friability) | Number of patients in the category with data available for baseline and the respective visit. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Number of Participants With Clinical Response at Week 8 | Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point. | Full analysis set | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Clinical Response at Week 16 | Clinical response is defined as a reduction in MMS of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Number of Participants With Endoscopic Improvement at Week 8 | Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher endoscopic score indicates more severe disease. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Endoscopic Improvement at Week 16 | Endoscopic improvement is defined as an endoscopic subscore of 0 or 1 (excluding friability) Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher endoscopic score indicates more severe disease. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Number of Participants With Mucosal Healing at Week 8 | Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score <2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity. | Full analysis set | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Mucosal Healing at Week 16 | Mucosal healing is defined as endoscopic remission (overall mucosal appearance at endoscopy subscore=0) and histological remission (Geboes score <2.0 based on rectal biopsy). The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. A higher score is associated with higher disease activity. | Full analysis set. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | Number of Participants With Reduction of Stool Frequency Relative to Baseline (Day 1) | Participants recorded stool frequency using an electronic subject diary on a daily basis. The stool frequency subscore (SFS) ranges from 0 to 3 according to the following scale: Score 0: Normal number of stools Score 1: 1 to 2 stools per day more than normal Score 2: 3 to 4 stools per day more than normal Score 3: 5 or more stools per day more than normal Decreasing score indicates improvement. | Patients in the category relative to the number of patients in the relevant analysis set and treatment group with data available | Posted | Count of Participants | Participants | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
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| Secondary | Number of Participants With Reduction of Rectal Bleeding Frequency Relative to Baseline | Participants recorded rectal bleeding in an electronic subject diary on a daily basis. Rectal bleeding score (RBS) is taken as the worst subscore of the three most recent scores within 7 days prior to the visit. The rectal bleeding subscore ranges from 0 to 3 according to the following scale: Score 0: No blood seen Score 1: Streaks of blood with stool less than half the time Score 2: Obvious blood with stool most of the time Score 3: Blood alone passed A lower score represents an improvement in rectal bleeding. | Number of participants in the relevant analysis set and treatment group with data available. | Posted | Count of Participants | Participants | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
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| Secondary | Partial Modified Mayo Score Change From Baseline | Partial Modified Mayo Score (pMMS) Change from baseline The pMMS is a composite score of UC disease activity based on the following 2 subscores:
The overall pMMS score ranges from 0 to 6 with higher scores representing more severe disease. | Reduction in least squares mean pMMS for all treatment groups at each visit | Posted | Least Squares Mean | 95% Confidence Interval | Score | Day 8, Day 29, Day 57, Day 85, Day 113, and Day 120 (End of Study) |
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| Secondary | Number of Participants With Reduction Relative to Baseline in Fecal Calprotectin at Weeks 8 and 16 | Fecal Calprotectin (FC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. FC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. Outcome will be measured based on a reduction in FC relative to baseline values. | Number of patients in the relevant analysis set and treatment group, with non-missing values of the parameter | Posted | Count of Participants | Participants | Week 8 and Week 16 |
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| Secondary | Number of Participants With Reduction Relative to Baseline in C Reactive Protein at Weeks 8 and 16 | CRP is an acute-phase protein which provides an objective criterion of inflammatory activity. CRP has a short half-life (19 hours) and therefore rises early after the onset of inflammation and rapidly decreases after resolution of the inflammation. It is induced by interleukin-6, TNF-alpha and other pro-inflammatory cytokines that are produced within the intestinal lamina propria. Outcome will be measured based on a reduction in CRP relative to baseline values. | Number of patients in the relevant analysis set and treatment group, with non-missing values of the parameter | Posted | Count of Participants | Participants | Week 8 and Week 16 |
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| Secondary | miRNA-124 Expression (Copy Number) in Whole Blood at Week 8 and Week 16 | Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at Week 8 and Week 16 using droplet digital PCR technology (ddPCR) on whole blood samples. "0" in the placebo column means "no signal", so BLQ (Below the level of quantification). | Only samples which were collected have been analyzed | Posted | Mean | Standard Deviation | copies number/cell | Week 8 and Week 16 |
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| Secondary | IL-6 Serum Concentrations | Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percentage of IL-6 | Day 1 |
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| Secondary | Number of Participants With Endoscopic Remission at Week 8 | Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher score represents more severe disease. | Number of participants with data for endoscopy relative to the number of patients in the relevant analysis set | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants With Endoscopic Remission at Week 16 | Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease;
A higher score represents more severe disease. | Number of patients in the category with data available for baseline and the respective visit. | Posted | Count of Participants | Participants | Week 16 |
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| Secondary | IL-10 Serum Concentrations | Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percentage of IL-10 | Day 1 |
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| Secondary | IL-1B Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percentage of IL-1B | Day 1 |
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| Secondary | TNFα Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percentage of TNFα | Day 1 |
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| Secondary | Change From Baseline in Infiltrate/Histopathology Using Robarts Histopathology Index (RHI) at Week 8 and Week 16 | Infiltrate/Histopathology (Rectal/Sigmoidal Biopsies) using the Robarts Histopathology Index (RHI) Week 8 and Week 16 biopsies will be compared to biopsies at baseline to assess the disease evolution at a tissue level, based on the Robarts Histological Index. The score ranges from 0 (no disease activity) to 33 (severe disease activity) is based on evaluation of 4 parameters: chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium and erosion and ulceration. A higher score indicates more severe disease. | Only samples which were collected have been analyzed. Patients that were evaluated with an endoscopy at week 16 are the subset of patients that did not achieve endoscopic improvement at week 8 | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Week 8 and Week 16 |
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| Secondary | Change From Baseline in Infiltrate/Histopathology - Geboes Score at Week 8 and Week 16 | The Geboes score is composed of 6 major grades that assess different aspects of the biopsy findings, with each grade having its own score range:
Subscales are summed across all 6 grades, final total score between 0 and 18 :
| Only samples which were collected have been analyzed and included baseline and data for week 8 or week 16. Patients that were evaluated with an endoscopy at week 16 are the subset of patients that did not achieve endoscopic improvement at week 8 | Posted | Least Squares Mean | 95% Confidence Interval | Score change from baseline | Week 8 and Week 16 |
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| Secondary | IL-6 Serum Concentrations | Serum samples from participants who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL6 was measured using the 8-plex assay on the ELLA Platform (Biotechne). All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-6 values - Day 1 IL-6 values/Day 1 IL-6 values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percent Change | Day 8, Day 29, Day 57, and Day 113 |
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| Secondary | IL-10 Serum Concentrations | Serum samples from patients who received ABX464 (25, 50 or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57, and Day 113). IL10 was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-10 values - Day 1 IL-10 values/Day 1 IL-10 values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percent Change | Day 8, Day 29, Week 8 and Week 16 |
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| Secondary | IL-1B Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113). IL1beta was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline IL-1B values - Day 1 IL-1B values/Day 1 IL-1B values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percent Change | Day 8, Day 29, Day 57 and Day 113 |
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| Secondary | TNFα Serum Concentrations | Serum samples from patients who received ABX464 (25, 50, or 100 mg) or placebo were collected during 5 visits (Day 1, Day 8, Day 29, Day 57 and Day 113 TNF-alpha was measured using the 8-plex assay on the ELLA Platform. All samples were tested in duplicate at the minimum required dilution. Baseline (Day 1) values are calculated as below: x1/arithmetic mean of baseline values x 100, where the arithmetic mean is defined by (x1 + x2+...+xn)/n (summing all baseline values and dividing by the total number of values n) The post baseline values are calculated as follow: post-baseline TNFα values - Day 1 TNFα values/Day 1 TNFα values)*100 | Only samples which were collected have been analyzed | Posted | Mean | Standard Error | Percent Change | Day 8, Day 29, Day 57 and Day 113 |
|
TEAEs and SAEs were collected from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug). All-cause mortality was reported from enrollment to end of study: up to 24 weeks in total, including 4 weeks screening (prior the first dose of study drug), 16 weeks of treatment, and 4 weeks safety follow-up (28 days after last dose of study drug).
All AEs and SAEs occurring from the time a patient consents to participate in the study until 4 Weeks after the last dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABX464, 100mg | ABX464 100mg: ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks | 0 | 64 | 4 | 64 | 45 | 64 |
| EG001 | ABX464, 50 mg | ABX464 50mg: ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks | 0 | 63 | 4 | 63 | 38 | 63 |
| EG002 | ABX464, 25mg | ABX464 25mg: ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks | 0 | 62 | 1 | 62 | 33 | 62 |
| EG003 | Matching Placebo | Matching placebo will be adminstrated orally (Capsules) and daily for 16 weeks Placebo: Two capsules of placebo once daily for 16 weeks | 0 | 64 | 4 | 64 | 30 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Dehydratation | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Facial paralysis | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Parosmia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensorimotor neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Restless legs syndrome | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dispepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces discoloured | Gastrointestinal disorders | Systematic Assessment |
| ||
| Frequent bowel mouvements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis erosive | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal polip | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Prothrombin time prolonged | Investigations | Systematic Assessment |
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| C-reactive protein increased | Investigations | Systematic Assessment |
| ||
| Lipase increased | Investigations | Systematic Assessment |
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| Alanine aminotranferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Glutamate Dehydrogenase increased | Investigations | Systematic Assessment |
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| International normalised ratio indreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count increased | Investigations | Systematic Assessment |
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| White cell count increased | Investigations | Systematic Assessment |
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| Blood cholesterol increased | Investigations | Systematic Assessment |
| ||
| Blood fibrilogen decreased | Investigations | Systematic Assessment |
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| Blood fibrilogen increased | Investigations | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
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| Hematocrit decreased | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | Systematic Assessment |
| ||
| Human chorionic gonadotropin increased | Investigations | Systematic Assessment |
| ||
| Intraocular pressure increased | Investigations | Systematic Assessment |
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| Liver function test increased | Investigations | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | Systematic Assessment |
| ||
| Troponin I increased | Investigations | Systematic Assessment |
| ||
| Troponin increased | Investigations | Systematic Assessment |
| ||
| Troponin T increased | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Anal abcsess | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Dermatophytosis | Infections and infestations | Systematic Assessment |
| ||
| Escherichia urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes Virus infection | Infections and infestations | Systematic Assessment |
| ||
| Paronychia | Infections and infestations | Systematic Assessment |
| ||
| Pyoderma | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Systematic Assessment |
| ||
| Tooth abscess | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal mycotic infection | Infections and infestations | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Coccydinia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ostheoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Tendon disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vitamin D deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Folate deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyposphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperlipasaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Iron deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema nodosum | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Ingrowing nail | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pityriasis Rosea | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin mass | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Congestive cardiomyopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Left ventricular hypertrophy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Palpitations | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tachycardia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Affective disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Depressed mood | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Cholelithiasis migration | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver disorder | Hepatobiliary disorders | Systematic Assessment |
| ||
| Liver injury | Hepatobiliary disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Breast cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal colic | Renal and urinary disorders | Systematic Assessment |
| ||
| Hypothiroidism | Endocrine disorders | Systematic Assessment |
| ||
| Eczema eyelids | Eye disorders | Systematic Assessment |
| ||
| Mite allergy | Immune system disorders | Systematic Assessment |
| ||
| Rectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Tooth extraction | Surgical and medical procedures | Systematic Assessment |
| ||
| Proctalgia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fabio Cataldi | ABIVAX | +33 (0) 1 53 83 08 41 | clinicaltrials@abivax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2021 | May 16, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000623073 | ABX464 |
Not provided
Not provided
Not provided
|
|
|
|
|
| Czechia |
|
|
| United States |
|
|
| Ukraine |
|
|
| Spain |
|
|
| Canada |
|
|
| Austria |
|
|
| Belgium |
|
|
| Poland |
|
|
| Italy |
|
|
| Slovakia |
|
|
| Slovenia |
|
|
| France |
|
|
| Serbia |
|
|
| Germany |
|
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
|
|
|
|
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 |
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 |
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 |
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| Matching Placebo |
Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
ABX464 50 mg: ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks |
| OG002 | ABX464 25 mg | ABX464 25 mg: ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo will be administered orally (capsules) and daily for 16 weeks Placebo: Two capsules of placebo once daily for 16 weeks orally (Capsules) and daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
| OG003 | Matching Placebo | Matching placebo was administered orally (two capsules) once daily for 16 weeks Two capsules of placebo once daily for 16 weeks |
|
|
|
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