Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

• Status: Completed
• Trial end date: 2017-07-12
• Target enrollment: 0
• Participant gender: Female

Summary

A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ICStudy, LLC
• Collaborator: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

1. A diagnosis of IC/BPS defined based on AUA guidelines as the following: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 months duration, in the absence of infection or identifiable causes, documented history or patient reported.

2. Only those patients with moderate to severe IC/BPS will be included in the study.

3. Able to provide informed consent to participate in the study and comply with study requirements

4. Able to provide written authorization for use and release of health and research study information

5. Written documentation of being provided California's Experimental Subject's Bill of Rights

6. Females ≥18 and ≤ 65 years of age previously diagnosed with interstitial cystitis/ bladder pain syndrome (IC/BPS) for a duration of greater than 6 months

7. Female patients of child-bearing potential must have a negative serum pregnancy test at Screening and use birth control while in the study.

8. O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18

9. No history of any cancer.

10. No bacterial cystitis in previous 1 month

11. No active herpes in previous 3 months

12. Never treated with cyclophosphamide

13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy)

14. Absence of bladder, ureteral or urethral calculi for previous 3 months

Exclusion criteria:

1. Symptoms are relieved at one month reevaluation visit after receiving IC/BPS behavior modification advice at screening visit.

2. Symptoms are relieved by antimicrobials, antibiotics, or other medications for IC/BPS

3. Pregnant women, lactating mothers, nursing mothers, women suspected of being pregnant and woman who plan to be pregnant during the course of the clinical trial

4. Males

5. Patients with inadequate renal, hepatic, or cardiac function

6. Patients with history of gross hematuria within 2 years.

7. Patients with the following medical history: Lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes

8. Patients with a history of tuberculosis (TB), recent exposure to TB, or recent travel to TB endemic regions. Patients should have a recent negative PPD (or negative CXR) prior to receiving treatment.

9. Patients who have undergone cystoscopy under anesthesia with bladder biopsy, hydrodistension, or fulguration of Hunner's ulcer within 3 months

10. Patients taking the following treatments for interstitial cystitis at Screening:

Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.

11. Patients with a history of receiving live vaccine including Flumist® influenza vaccine in the past 3 months.

12. Patients with a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.

13. Patients with a history of alcohol, analgesic or drug abuse within 2 years of Screening.

14. Patients with a history of any cancer.

15. Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B).

16. Patients with a history of invasive fungal infections, recent travel to regions endemic for the following invasive fungal infections: San Joaquin Fever, aspergillosis, histoplasmosis, candidiasis, coccidiodomycosis, blastomycosis, and pneumocystosis.

17. Patients with a history of diabetes mellitus.

18. Patients with a history of a neurologic disease included but not limited to central demyelinating diseases, including multiple sclerosis; and a history of peripheral demyelinating disease, including Guillain-Barre syndrome.

19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.