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 LTE (Long Term Extension)
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 LTE. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of the initial Screening Visit. 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. Participants entering the LTE will continue to receive the SC dose of ALTB-268 weekly or biweeky, up to 2 years. Upon completion of the LTE, study participants will be asked to return for an end of study visit in approximately 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ALTB-268 drug product (DP) for SC injection is supplied as a sterile and preservative-free frozen solution or lyophilized powder. All excipients used in the DP formulation are of multi-compendial quality and have precedence for use in parenteral products.
San Diego Gastroenterology
San Diego, California, United States
Efficacy - change in mMS
Change from baseline in mMS at Week 12. The modified Mayo score (mMayo Score) is a measure of disease activity in ulcerative colitis. It is based on stool frequency (SF), rectal bleeding (RB), and endoscopic subscore (ES). The mMS ranges from 0 to 9. A lower mMS means less severe UC, and a higher mMS means more severe UC.
Time frame: week 12
Efficacy - clinical response
The proportion of subjects with clinical response at Week 12, defined as a decrease from baseline in the mMS of ≥ 2 points AND at least a 30% reduction from the baseline score, AND a decrease in the RB subscore of ≥ 1 point or an absolute RB score of 0 or 1.
Time frame: week 12
Efficacy - clinical remission
The proportion of subjects with clinical remission at Week 12, defined as mMS of ≤ 2 points, with a SF subscore of ≤ 1 point, a RB subscore of 0, and an endoscopic subscore of ≤ 1 point.
Time frame: week 12
Efficacy - endoscopic improvement
The proportion of subjects with endoscopic improvement, defined as a centrally read endoscopy score of ≤1 at Week 12.
Time frame: week 12
Efficacy - endoscopic remission
The proportion of subjects with endoscopic remission, defined as a centrally read endoscopy score of 0 at Week 12.
Time frame: week 12
Efficacy - histological remission (RHI)
Histological remission, defined as a Robarts Histopathology Index (RHI) Score of ≤ 3 at Week 12.
Time frame: week 12
Efficacy - change from baseline in Geboes score
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...and 14 more locations
Change from baseline in Geboes score at week 12.
Time frame: week 12
Efficacy -Change from baseline in pMS
change from baseline in pMS at Week 12
Time frame: week 12
Efficacy - change in individual mMS subscores
Change in individual mMS subscores at week 12
Time frame: week 12
Efficacy - change from baseline in pMS
Time frame: week 12 and week 52
Efficacy - change in mMS
Change in individual mMS subscores
Time frame: week 12 and week 52
Efficacy - change in IBDQ score
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at Week 12
Time frame: week 12
Efficacy - change from baseline in fecal calprotectin
change from baseline in fecal calprotectin at Week 12
Time frame: week 12
Efficacy - change from baseline in C-reactive protein (CRP)
change from baseline in CRP at Week 12
Time frame: week 12