Louisiana Research Center | Shreveport, LA
Status and phase
Conditions
Treatments
About
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase.
Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268 followed by weekly doses of ALTB-268 for 12 weeks. Primary efficacy endpoint will be evaluated at week 12.
Week 12 dosing will occur during the 40 wks Maintenance Phase.
During 40 weeklong maintenance phase SC doses of ALTB-268 will be administered every other week. At week 52, all subjects will have an endoscopy performed and efficacy and safety evaluation will take place.
Full description
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC.
The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of SV1. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268. followed by a weekly maintenance dose of ALTB-268 in the 12 week Induction Study Phase. During the Induction Phase, study participants will be evaluated weekly at V0 (Day 1), V1 (Week 1), V2 (Week 2), V3 (Week 3), V4 (Week 4), V5 (Week 5), V6 (Week 6), V7 (Week 7), V8(Week 8), V9 (Week 9), V10 (Week 10), and V11 (Week 11) and V12 (Week 12; End of Induction Phase). Participants entering the maintenance study phase will continue to receive the SC dose of ALTB-268 every two weeks, up to week 52. Upon completion of the maintenance study phase, study participants will be asked to return for an end of study visit in approximately 4 weeks, for end of study visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adult participants 18 to 75 years old, inclusive, at Screening.
Willing to provide informed consent and to be compliant with the schedule of study visits and protocol assessments.
Diagnosis of UC established at least 12 weeks prior to Screening by standard clinical and endoscopic evidence and corroborated by a histopathology report.
Moderately to severely active UC, at the time of Screening, defined as a modified Mayo Score (mMS) of 5-9, inclusive, with an endoscopic subscore of ≥ 2 (from central reading), and a rectal bleeding (RB) subscore of ≥ 1.
Evidence of active UC, extending proximal to the rectum with ≥ 15 cm of involved colon.
Stable doses of concomitant medications:
Previous treatment with at least one biologic therapy that demonstrated an inadequate response and/or loss of response.
Negative pregnancy test during Screening and Day 1 (V0) in females of childbearing potential.
Females with reproductive potential must be sexually abstinent or be willing to use a highly effective method of contraception from study start to ≥ 3 months after the final dose of the study drug. Highly effective methods of contraception include:
Male subjects must be either surgically sterile (must have documented proof), agree to be sexually abstinent, or use a double-barrier method of birth control (e.g., condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration to ≥ 3 months after the final dose administration.
Male subjects must agree to refrain from donating sperm from first study drug administration to ≥ 3 months after final dose administration.
Exclusion criteria
Diagnosis of Crohn's colitis, colitis yet to be classified, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC), or radiation-induced colitis.
Ulcerative colitis limited to the rectum (ulcerative proctitis).
Presence of short bowel syndrome.
History of colectomy, or presence of an ileostomy or colostomy.
History of, or active colonic mucosal dysplasia.
Treatment with any intravenous (IV) corticosteroid or rectal therapy during the Screening period.
Treatment with any calcineurin inhibitor (e.g., cyclosporine, tacrolimus) within 4 weeks prior to Screening.
Treatment with NSAIDs within 4 weeks prior to Screening. Short-term use (<7 days) of NSAIDs for non-UC related symptoms is allowed.
Treatment with tofacitinib or other Janus Kinase (JAK) inhibitors within 4 weeks prior to Screening.
Treatment with sphingosine-1-phosphate receptor (S1PR) modulators within 4 weeks prior to Screening.
Biologic therapy within 56 days or 5 half-lives (whichever is longer) prior to Screening. Confirmation of undetectable or non-therapeutic serum levels, as assessed by the Investigator, will allow for eligibility.
Tube feeding, defined formula diets, or parenteral alimentation/nutrition within 3 weeks of first dosing.
Treatment with oral antibiotics within 4 weeks prior to Screening or IV antibiotics within 8 weeks prior to Screening.
Vaccination with a live or live-attenuated vaccine within 4 weeks prior to Screening.
History of dysplasia or malignancy in the past 5 years, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Subjects with a current or recent history of severe, progressive, or uncontrolled cardiac (including uncontrolled hypertension), renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological (e.g., history of seizures) disease, or any other severe comorbidity that, in the opinion of the Investigator, could confound the study results or put the subject at unreasonable risk.
Significant screening electrocardiogram (ECG) abnormalities, including evidence of acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block.
For males, a QTc interval (Fridericia's correction) of >450 ms, and for females, a QTc interval (Fridericia's correction) of >470 ms.
Any of following laboratory abnormalities during the Screening period. If values are initially outside prescribed limits, the evaluation may be repeated once within the
Screening period to determine eligibility:
Human immune deficiency virus (HIV) infection or known HIV-related malignancy.
Acute or chronic hepatitis B (HBV) or hepatitis C (HCV), or carrier status. Subjects with anti-HBc (hepatitis B core) antibodies (Ab) but with undetectable anti-HBs (hepatitis B surface) Ab should be excluded.
Positive immunoglobulin M (IgM) Ab titers in the presence of negative immunoglobulin G (IgG) Ab titers to Epstein-Barr virus (EBV).
Positive stool test for ova or parasites, positive stool culture for pathogens, or positive stool toxin assay for Clostridium difficile at Screening.
Active cytomegalovirus (CMV) infection at Screening, as assessed by the Investigator.
Positive QuantiFERON® TB test at Screening for latent Mycobacterium tuberculosis (TB) infection. If a QuantiFERON® TB test is indeterminate, the test should be repeated. If the result is again indeterminate, the subject should be excluded.
Subjects with a history of latent TB infection who received or are receiving an appropriate and documented course of therapy can be included if the screening examination and a chest x-ray performed within 3 months prior to Screening revealed no evidence of current active infection.
History of any opportunistic infection within 12 weeks of first dosing.
Any current or recent symptoms/signs of infection, except nasopharyngitis, within 4 weeks of first dosing.
Cirrhosis or active alcohol abuse, pr the judgment of the Investigator.
History of drug abuse according teo the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria within 12 months prior to Screening or a positive drug screening test.
Currently breast feeding, or pregnant.
Known hypersensitivity or intolerance to ALTB-268 or any of its excipients.
Participation in another clinical trial AND having received investigational medication within 30 days or 5 half-lives (whichever is longer) prior to Screening or having used an investigational device treatment within 30 days prior to Screening. Concurrent participation in an observational or long-term follow-up study and not actively receiving an investigational drug or device treatment may be eligible for participation in this study.
Inability to comply with the study protocol, in the opinion of the Investigator.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Loading...
Central trial contact
Simona Reed, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal