CC-99677-AS-001
This is a study to to evaluate the efficacy and safety of CC-99677 in Subjects with Active Ankylosing Spondylitis (AS).
Minimum Age
18
18 Years and Older
No Older Than 65
Diagnosis
AS
Ankylosing Spondylitis
PLACEBO CONTROLLED
Yes
Approx. 1 in 3 subjects will receive placebo
DURATION
16
Total Duration is 16 Weeks
STIPEND
$40
$40 Per Visit, $630 Max
Patient Benefits
Patients who screen and then enroll in the study will receive:
- Doctor Assessments
- Lab work and Safety Follow-ups
- Study drug (active or placebo)
- $40.00 per completed study visit ($630 Maximum for the course of the study.)
Study Duration for Patients
The total study duration is approximately 36-weeks which consists of approximately 10 visits during the course of the study.
The study consists of three periods:
- Screening Period (2 to 6 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Study Treatment Period (12 weeks). This Study Treatment period includes a Double-Blind Study Treatment Period (12 weeks). Double-blind means you and your study team will not know if you will receive the active study drug or a placebo.
- Safety Follow-Up Visit (SFU visit) (4 weeks, after the last dose of the study drug or placebo) This visit will ensure you have no long-term safety concerns after the end of treatment.
The study may also have some unplanned visits, most commonly for repeat lab work.
CC-99677
CC-99677 is an investigational oral medication for the treatment of Ankylosing Spondylitis
Study Location
600 Aviator Ct.
Vandalia, OH 45377
Inclusion Criteria
The following must be met in order to qualify for the study.
- Subjects must be at least 18 years of age, and no older than 65.
- Documented diagnosis of Ankylosing Spondylitis.
- Women of childbearing potential will be tested for pregnancy at the screening visit.
- Subjects must agree to be abstinent or use a highly effective form of contraception while on the study and for 28 days after the final dose of the study drug.
- Subjects must agree to limit exposure to Ultraviolet light.
Exclusion Criteria
Patients with any of the following are ineligible to enroll in the study.
- Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study
- Subjects that have radiographic evidence of total ankylosis of the spine
- Subjects that have evidence of significant cardiac, renal, neurologic, psychiatric, endocrinologic (including uncontrolled diabetes, defined as hemoglobin A1c (HbA1c) ≥ 9.5%), metabolic, hepatic disease, or gastrointestinal disease.
- Subjects that have uncontrolled severe psoriasis (defined as Body Surface Area > 10%)
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.
1-833-STAT-833
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Study Investigator
Dr. Sanford Wolfe, D.O.
Principal Investigator
Dr. Wolfe is a graduate of Des Moines University College of Osteopathic Medicine and has been practicing Rheumatology for over 40 years. Dr. Wolfe is board certified in Internal Medicine and Rheumatology. Dr. Wolfe is a renowned leader in regards to clinical research trials, with over 20 years of experience and led more than 120 studies within the Rheumatology therapeutic area.