AzTrials
AzTrials

Crohn DiseasePhase 2NCT05471492

Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease

A Phase 2 study testing Investigational Product in people with Crohn Disease, run by Telavant, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease
What is being tested?
Investigational Product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jul 2023to 15 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline;
  • Central read total SES-CD score of ≥7. For isolated ileal disease, SES-CD total score should be ≥4;
  • An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0;
  • CDAI between 220 and 450 inclusive;
  • Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD

Who cannot join

  • Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;
  • Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;
  • Strictures or stenosis with obstructive symptoms;
  • Short bowel syndrome;
  • History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;
  • Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma;
  • History of bowel surgery within 6 months prior to baseline.

About this study

Official title: A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity

Conditions
Crohn Disease
Being tested
Investigational Product, Placebo
Keywords
Crohn Disease, PF-06480605, SES-CD, CDAI,
Medical subject headings
Crohn Disease, Anemia, Dyserythropoietic, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational ProductDrug

    PF-06480605 150 mg

  • PlaceboDrug

    Placebo

Study groups in NCT05471492
Study groupRoleWhat they receive
Treatment Group 1ExperimentalPF-06480605 150 mg
Receives: Drug: Investigational Product
Treatment Group 2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with endoscopic response 50

    Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease.

    Measured: Week 14

Secondary outcomes (14)

  1. Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission

    Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

    Measured: Week 14

  2. Proportion of participants achieving endoscopic remission

    Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1

    Measured: Week 14

  3. Proportion of participants achieving endoscopic mucosal healing

    Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD

    Measured: Week 14

  4. The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170

    Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32 to 224. A higher score indicates better quality of life. A score of at least 170 corresponds to clinical remission.

    Measured: Week 14

  5. Proportion of participants achieving endoscopic response

    Endoscopic response defined as improvement of SES-CD score at least 50% from baseline

    Measured: Week 52

  6. Proportion of participants with a CDAI clinical remission

    Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.

    Measured: Week 52

  7. Proportion of participants achieving endoscopic remission

    Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1

    Measured: Week 52

  8. Proportion of participants achieving endoscopic mucosal healing

    Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD

    Measured: Week 52

  9. Proportion of participants with a CDAI clinical remission

    CDAI < 150 overtime during induction treatment period

    Measured: up to week 52

  10. Proportion of participants with a CDAI clinical response

    As defined by a decrease from baseline in CDAI score of at least 100 points or more

    Measured: Up to week 52

  11. Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response

    PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline

    Measured: Up to week 52

  12. Proportion of participants achieving PRO2 clinical remission

    PRO2 clinical remission is defined as SF≤2.5 and AP≤1

    Measured: Up to week 52

  13. Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.

    Measured: up to week 52

  14. Incidence of development of severe and serious infections

    Measured: Up to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2022
  2. Study start30 Jul 2023 (estimated)
  3. Primary completion15 Aug 2026 (estimated)
  4. Study completion15 Aug 2026 (estimated)

Why it stopped: Trial not started; change in Sponsor, a new trial to be registered by the new Sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to one of two groups in parallel for the duration of the study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05471492
Sponsor's protocol ID
B7541009
Other IDs
2022-001259-18
Status last verified
Oct 2023
First submitted
18 Jul 2022
Last updated
19 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational Product in people with Crohn Disease, run by Telavant, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with endoscopic response 50 (time frame: Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05471492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in