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HealthyPhase 1NCT04457960

A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

A Phase 1 study testing JNJ-66525433 in people with Healthy and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Colitis, Ulcerative
What is being tested?
JNJ-66525433
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
1 siteGermany
Study dates
1 Jul 2020to 13 Oct 2021
Phase
Phase 1
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • For Part 1 and Part 2, healthy volunteers
  • Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height), inclusive, and a body weight of no less than 50 kilogram (kg) and maximum weight of 100 kg
  • Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission
  • For Part 3, participants with ulcerative colitis (UC)
  • Have a clinical diagnosis of UC at least 3 months before screening
  • Have moderately to severely active UC, defined as a Week 0 mayo score of 6 to 12, inclusive, based on central read of the video endoscopy performed during the screening
  • Have a greater than or equal to (>=) 2 endoscopy subscore of the Week 0 mayo score based on central read of the video endoscopy performed during the screening

Who cannot join

  • For Part 1 and Part 2, healthy volunteers
  • History of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Known allergies, hypersensitivity, or intolerance to antisense oligonucleotides, JNJ-66525433 or its excipients
  • For Part 3, participants with UC
  • Has UC limited to the rectum only or to <20 centimeter (cm) of the colon evaluated by endoscopy at screening
  • Presence of a stoma
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  • Presence or history of a fistula at any time
  • COVID-related
  • If a participant is excluded due to recent Coronavirus disease (COVID-19) related features, the reason for screen failure should be documented in the case report form under the exclusion criterion of having a condition for which participation would not be in the participant's interest or could confound study assessments
  • The field of COVID-related testing (for presence of, and immunity to, the severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] virus) is rapidly evolving. Additional testing may be performed as part of screening and/or during the study if deemed necessary by the investigator and in accordance with current regulations / guidance from authorities / standards of care

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charite Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433

The purpose of this study is to evaluate safety and tolerability of JNJ 66525433 compared with placebo after administration of: 1) single ascending oral doses of JNJ 66525433 administered to healthy participants (Part 1), 2) multiple, ascending oral doses of JNJ 66525433, administered to healthy participants once daily over 14 consecutive days (Part 2), and 3) multiple oral doses of JNJ 66525433, administered once daily over 14 consecutive and once daily over 42 consecutive days in participants with ulcerative colitis (UC) (Part 3).

Being tested
JNJ-66525433, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • JNJ-66525433Drug

    Participants will receive JNJ-66525433 oral capsules.

  • PlaceboDrug

    Participants will receive matching placebo oral capsules.

Study groups in NCT04457960
Study groupRoleWhat they receive
JNJ-66525433ExperimentalParticipants will receive JNJ-66525433 in increasing dose level 1 to dose level 4 in Parts 1, 2, and dose level 3 in part 3.
Receives: Drug: JNJ-66525433
PlaceboPlacebo comparatorParticipants will receive matching placebo in Parts 1, 2 and 3.
Receives: Drug: Placebo

What is being measured

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

  1. Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. Any AE occurring at or after the initial administration of study intervention through the day of last dose plus 30 days will be considered as TEAE.

    Measured: Up to 224 Days

  2. Part 1, 2 and 3: Number of Participants with Vital Sign Abnormalities

    Number of participants with vital sign abnormalities (temperature), pulse/heart rate, respiratory rate and blood pressure) will be reported.

    Measured: Up to 224 Days

  3. Part 1, 2 and 3: Number of Participants with Physical Examination Abnormalities

    Number of participants with physical examination abnormalities will be reported.

    Measured: Up to 224 Days

  4. Part 1, 2 and 3: Number of Participants with Hematology Laboratory Abnormalities

    Number of participants with hematology laboratory abnormalities will be reported.

    Measured: Up to 224 Days

  5. Part 1, 2 and 3: Number of Participants with Chemistry Laboratory Abnormalities

    Number of participants with chemistry laboratory abnormalities will be reported.

    Measured: Up to 224 Days

  6. Part 1, 2 and 3: Number of Participants with Urinalysis Laboratory Abnormalities

    Number of participants with abnormalities in urinalysis will be reported.

    Measured: Up to 224 Days

  7. Part 2 and 3: Number of Participants with Abnormalities in High Sensitivity C- Reactive Protein (hs-CRP)

    Number of participants with abnormalities in hs-CRP will be reported using a validated, high sensitivity CRP assay.

    Measured: Up to 224 Days

  8. Part 2 and 3: Number of Participants with Abnormalities in Fecal Calprotectin

    Assays for fecal calprotectin will be performed using a validated method.

    Measured: Up to 224 Days

  9. Part 2 and 3: Incidence of Enteric Pathogens in Stool Samples

    Stool culture and Clostridium difficile toxin assay will be used for enteric pathogen assessment.

    Measured: Up to 224 Days

  10. Part 1, 2 and 3: Number of Participants with Electrocardiogram (ECG) Abnormalities

    Number of participants with ECG abnormalities will be reported.

    Measured: Up to 224 Days

Secondary outcomes (10)

  1. Part 1, 2 and 3: Plasma Concentrations of JNJ-66525433

    Plasma concentrations of JNJ-66525433 will be reported.

    Measured: Up to 224 Days

  2. Part 1: Plasma Concentrations of JNJ-66525433 After Fasted or Fed Dosing

    Plasma concentrations of JNJ-66525433 after fasted or fed dosing will be reported.

    Measured: Up to Day 14

  3. Part 3: Mayo Score

    Mayo scoring system is used for assessment of ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each ranges from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12, where higher score indicates severe disease.

    Measured: Up to Day 84

  4. Part 3: Partial Mayo Score

    Partial Mayo score is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, and physician's global assessment) and ranges from 0 to 9 points. Higher score indicates severe disease.

    Measured: Up to Day 70

  5. Part 3: Endoscopic Subscore

    Endoscopy sub-score ranges from 0 to 3 where; 0 = normal or inactive disease; 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = severe disease (spontaneous bleeding, ulceration).

    Measured: Up to Day 84

  6. Part 3: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

    IBDQ18 is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Measured: Days 1, 7, 14, 28, 43, 70 and 84

  7. Part 2 and 3: Target Engagement of Messenger Ribonucleic Acid (mRNA) Levels

    Levels of mRNA knockdown will be reported to assess target engagement in biopsy tissue by dose level over time.

    Measured: Up to 182 Days

  8. Part 2 and 3: Tissue Biopsy JNJ-66525433 Concentrations

    Tissue biopsy concentrations of JNJ-66525433 will be reported.

    Measured: Up to 182 Days

  9. Plasma Concentrations of JNJ-66525433 After Two Meal Timing Conditions

    Plasma concentrations of JNJ-66525433 after two meal timing condition (fed state to modified fasted state) will be reported (if conducted).

    Measured: Up to 22 Days

  10. Faecal Concentrations of JNJ-66525433 After Two Meal Timing Conditions

    Stool assessment will be done to characterize the presence of JNJ-66525433 after two meal timing conditions (fed state to modified fasted state) will be reported (if conducted).

    Measured: Predose, up to 120 hours postdose

Timeline

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

  1. First posted7 Jul 2020
  2. Study start1 Jul 2020
  3. Primary completion13 Oct 2021
  4. Study completion13 Oct 2021

Why it stopped: Sponsor Decision.

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457960
Sponsor's protocol ID
CR108764
Other IDs
2018-003743-29, 66525433IBD1001, 2018
Status last verified
Jan 2025
First submitted
1 Jul 2020
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-66525433 in people with Healthy and Colitis, Ulcerative, run by Janssen Research & Development, LLC at 1 site in Germany.

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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 stopped early (reason given: Sponsor Decision.). Results are not available in the source record.

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?

Part 1, 2 and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability (time frame: Up to 224 Days). The study lists 10 primary outcomes in all. 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 NCT04457960.

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 3 Feb 2025.

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