Ongoing Clinical Trials

Ulcerative Colitis

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in combination with Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults with Ulcerative Colitis

Sponsor: PI initiated
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel
Email: [email protected]
Phone: 713-500-6679

Main Inclusion Criteria:

  • Adult ≥ 18 years of age diagnosed with UC in remission stage.
  • History of active UC in the past 12 months based on standard clinical, endoscopic, or histologic criteria.
  • Remission of UC based on clinical grounds (partial Mayo score of ≤2 with each subscore ≤1), and on stable maintenance therapy, defined as stable dose of immunomodulator (azathioprine/imuran, 6-mercaptopurine/6-MP) for 3 months and other medications without change for 1 month.

Ulcerative Colitis

A Randomized, Open-label, Pilot Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis

Sponsor: PI initiated
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel
Email: [email protected]
Phone: 713-500-6679
Main Inclusion Criteria:

  • Adult ≥ 18 years of age diagnosed with active UC.
  • Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3)

Subject receives any drug including a biologic in standard doses for UC treatment during the study treatment period.

Ulcerative Colitis

An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy with Tofacitinib in Adult Patients with Moderately to Severely Active Ulcerative Colitis

Sponsor: Takeda
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel
Email: [email protected]
Phone: 713-500-6679
Main Inclusion Criteria:

  • Has moderately to severely active UC at screening as determined by a complete Mayo score (including PGA) of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2.
  • Has evidence of UC extending proximally to the rectum (≥15 cm of involved colon).
  • Has demonstrated an inadequate response to, loss of response to, or intolerance to no more than 2 TNF-α antagonists

Ulcerative Colitis

A Phase 2b multi-national, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study followed by a long-term extension to evaluate the efficacy and safety of SAR442970 in adult participants with moderate to severe ulcerative colitis

Sponsor: Sanofi-Aventis Recherche & Development
Principal Investigator: Tugrul Purnak MD
Study Coordinator: Iram Abbasi
Email: [email protected]
Phone: 713-500-6679
Main Inclusion Criteria

Adults with moderately to severely active UC

Must have received prior treatment for UC (either “a” or “b” below or combination of both):

  • a) History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids (oral or intravenous), MTX, AZA, or 6MP or history of corticosteroid dependence AND history of no prior exposure to ATs, such as a biologic agent used to treat UC (eg, anti-TNFs, anti-integrins, anti-IL-12/IL-23, or anti-IL-23) or advanced small molecules used to treat UC (JAKis or S1PR modulators).
  • b) History of inadequate response to, loss of response to or intolerance to treatment with >1 AT such as a biologic agent used to treat UC (eg, anti-TNFs, anti-integrins, anti-IL-12/IL-23, or anti-IL-23) or advanced small molecules used to treat UC (JAKis or S1PR modulators).

Crohn’s Disease

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy with Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn’s Disease (CD)

Sponsor: Takeda
Principal Investigator: Andrew W. DuPont, MD, MSPH
Study Coordinator: Urvashi Patel
Email: [email protected]
Phone: 713-500-6679
Main Inclusion Criteria:

  • Has moderately to severely active CD at Screening, defined as both of the following:a) a CDAI score ≥220 and <450, and b) a SES-CD ≥6 (≥4 if isolated ileal disease).
  • Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist (ustekinumab or risankizumab) or at least 1 TNFi (infliximab or biosimilar, adalimumab, or certolizumab pegol), at doses approved for the treatment of CD:
  1. Inadequate response after completing the full induction regimen;
  2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
  3. Intolerance (a significant AE that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion—related and hypersensitivity reactions including anaphylaxis, and liver injury).

Note: Participants with primary nonresponse to ≥2 agents are not eligible. Participants with intolerance to 2 agents may be eligible at the investigator’s discretion.

Crohn’s disease

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely

Active Crohn’s Disease (GARNET)

Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Principal Investigator: Tugrul Purnak MD
Study Coordinator: Iram Abbasi
Email: [email protected]
Phone: 713-500-6679
Main Inclusion Criteria:

Adults with moderately to severely active CD confirmed during the Screening Period with the following criteria:

  1. A CDAI score of 220 to 450 inclusive
  2. An SES-CD score of ≥6. If disease is isolated to the ileum, SES-CD score ≥4
  3. hs-CRP >5 mg/L

Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments (including corticosteroids, immunosuppressants, and/or advanced therapies for CD)