Crohn's DiseasePhase 1NCT05028946
A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
A Phase 1 study testing Foralumab in people with Crohn's Disease, run by Tiziana Life Sciences LTD.
Trial summary
The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Foralumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 7 Nov 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has been diagnosed with active CD as confirmed by endoscopic examination with histological confirmation for at least 12 weeks before the screening visit; only study participant who has endoscopic examination by colonoscopy of disease location that includes ileocolon and/or colon and who has a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥3 will be enrolled in the study.
- Participant has a CDAI ≥220 but ≤450 points (that is, participant has moderate to severely active disease despite current treatment).
- Participant is naïve to anti-CD3 therapy.
- Non-smoker or use of nicotine or other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, e-cigarettes or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) will not be allowed from 3 months before the screening visit until the final follow-up visit.
- Participant's current regimen of concomitant medication(s) falls within the definitions provided in the protocol.
- Participant must weigh ≥50 kg at the time of signing informed consent.
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- Male or female
- Sexually active male participant must agree to use highly effective contraception as detailed in of this protocol during the treatment period and for at least 10 weeks after the last dose of study medication (or longer if required by local approved label).
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP). ii) A WOCBP who agrees to follow the guidance for highly effective contraception during the treatment period and for at least 10 weeks after the last dose of study medication (or longer if required by local approved label).
Who cannot join
- Participant has symptomatic coronavirus disease of 2019 (COVID-19) or a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result prior to screening.
- Participant has a suspected or confirmed diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Participant with any known fistula involving the gastrointestinal (GI) tract (except for perianal fistula).
- Participant with symptomatic stricturing type disease at the time of the screening visit.
- Participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of >3 small bowel resections.
- Participant has a functional colostomy or ileostomy. Exception: A participant who has had a temporary stoma in the past, which has been reversed, may be enrolled.
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- Participant has had a surgical bowel resection within 6 months before the screening visit or is planning any resection at a time while enrolled in the study.
- Participant with clinical suspicion of intra-abdominal abscess(es). If a participant receives treatment for the abscess, they may be rescreened.
- Participant currently requires or is anticipated to require surgical intervention for CD during the study.
- Participant has a current or recent history (within 6 months before the screening visit) of clinically relevant renal, hepatic, hematological, GI (other than CD), endocrine, pulmonary, neurological, or cerebral disease including blood dyscrasia (for example, pancytopenia, aplastic anemia), demyelinating disease (for example, multiple sclerosis, myelitis, optic neuritis), or ischemic heart disease.
- Participant has known history of or current clinically active infection with histoplasma, coccidioides, paracoccidioides, pneumocystis, tuberculous mycobacteria, nontuberculous mycobacteria, blastomyces, aspergillus, legionella, or listeria.
- Participant with evidence of an acquired or congenital immunodeficiency state, including, but not limited to, known human immunodeficiency virus (HIV) infection, agammaglobulinemia, organ transplantation, T cell deficiencies, or human T cell lymphotropic virus type 1.
- Participant has a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within the 4 weeks prior to the screening visit (including Herpes zoster), infection requiring intravenous (IV) antibiotic use within the 4 weeks prior to the screening visit or oral antibiotic use within the 2 weeks prior to the screening visit.
- Participant has a concurrent malignancy or a history of any malignancy at any time (including nonmelanoma skin cancer).
- Participant has concurrent bowel dysplasia or a history of bowel dysplasia in the 5 years before the screening visit.
- Participant has a history of a lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of lymphoproliferative disease at any time.
- Participant has a known hypersensitivity to any excipients of the investigational medicinal product (IMP) or its ingredients.
- Participant is currently receiving chronic concomitant systemic antibiotic therapy for diseases other than CD or acne.
- Participant received any live (includes attenuated) vaccination within the 10 weeks prior to the screening visit or intending to receive during the study (inactivated vaccinations are permitted at any time prior to and during the study) or within 3 months after last dose of certolizumab pegol (CZP) or foralumab.
- Participant has a positive fecal laboratory test result for enteric pathogens and/or ova and parasites at the screening visit.
- Participant who has evidence of, or treatment for clostridium difficile infection or other intestinal pathogen, within 28 days prior to first dose of study medication.
About this study
Official title: A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease
The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).
Read the detailed description
Four different doses of foralumab enteric coated capsules will be studied for safety and tolerability in a MAD format. Participants in the sequential MAD cohorts will receive treatment when the safety data of one cohort are reviewed by the Data Safety Monitoring Board (DSMB) and are deemed favorable to proceed with the next treatment in the subsequent cohort.
- Conditions
- Crohn's Disease
- Being tested
- Foralumab
- Keywords
- Anti-CD3 Monoclonal Antibody, Inflammatory bowel disease, Oral anti-CD3
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForalumabDrug
Also called Human anti-CD3 monoclonal antibody (mAb)
Foralumab will be administered per dose and schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Foralumab Dose Level 1 | Experimental | Participants will receive foralumab enteric coated capsules at dose level 1, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). Receives: Drug: Foralumab |
| Cohort 2: Foralumab Dose Level 2 | Experimental | Participants will receive foralumab enteric coated capsules at dose level 2, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). Receives: Drug: Foralumab |
| Cohort 3: Foralumab Dose Level 3 | Experimental | Participants will receive foralumab enteric coated capsules at dose level 3, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). Receives: Drug: Foralumab |
| Cohort 4: Foralumab Dose Level 4 | Experimental | Participants will receive foralumab enteric coated capsules at dose level 4, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). Receives: Drug: Foralumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events categorized and graded via CTCAE
Measured: Day 1 up to Day 14
Secondary outcomes (1)
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Day 5 and Day 12
The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI scores generally range from 0 to 600 points. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline, Day 5 and Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 May 2022 (estimated)
- Primary completion7 Jul 2023 (estimated)
- Study completion7 Nov 2023 (estimated)
Why it stopped: For business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028946
- Sponsor's protocol ID
- TILS-014
- Other IDs
- 2021-002698-24
- Status last verified
- Oct 2022
- First submitted
- 24 Aug 2021
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT05028946
- Acronym / sponsor ID
- TILS-014
- Conditions
- Crohn's Disease
- Keywords
- Anti-CD3 Monoclonal Antibody, Inflammatory bowel disease, Oral anti-CD3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: For business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 7 Jul 2023 (estimated)
- Study completion
- 7 Nov 2023 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to establish the safety and tolerability of multiple ascending doses (MAD) of foralumab enteric coated capsules administered orally, once daily for 5 days per week over 2 weeks in participants with moderate to severely active Crohn's Disease (CD).
Detailed description
Four different doses of foralumab enteric coated capsules will be studied for safety and tolerability in a MAD format. Participants in the sequential MAD cohorts will receive treatment when the safety data of one cohort are reviewed by the Data Safety Monitoring Board (DSMB) and are deemed favorable to proceed with the next treatment in the subsequent cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Foralumab Dose Level 1 | Experimental | Drug: ForalumabParticipants will receive foralumab enteric coated capsules at dose level 1, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). |
| Cohort 2: Foralumab Dose Level 2 | Experimental | Drug: ForalumabParticipants will receive foralumab enteric coated capsules at dose level 2, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). |
| Cohort 3: Foralumab Dose Level 3 | Experimental | Drug: ForalumabParticipants will receive foralumab enteric coated capsules at dose level 3, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). |
| Cohort 4: Foralumab Dose Level 4 | Experimental | Drug: ForalumabParticipants will receive foralumab enteric coated capsules at dose level 4, administered orally once daily for 2 weeks (5 consecutive days in each week with a 2-day undosed safety assessment period after each 5 day treatment period). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant has been diagnosed with active CD as confirmed by endoscopic examination with histological confirmation for at least 12 weeks before the screening visit; only study participant who has endoscopic examination by colonoscopy of disease location that includes ileocolon and/or colon and who has a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥3 will be enrolled in the study.
- Participant has a CDAI ≥220 but ≤450 points (that is, participant has moderate to severely active disease despite current treatment).
- Participant is naïve to anti-CD3 therapy.
- Non-smoker or use of nicotine or other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, e-cigarettes or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) will not be allowed from 3 months before the screening visit until the final follow-up visit.
- Participant's current regimen of concomitant medication(s) falls within the definitions provided in the protocol.
Key exclusion criteria (21 listed)
- Participant has symptomatic coronavirus disease of 2019 (COVID-19) or a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test result prior to screening.
- Participant has a suspected or confirmed diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Participant with any known fistula involving the gastrointestinal (GI) tract (except for perianal fistula).
- Participant with symptomatic stricturing type disease at the time of the screening visit.
- Participant has had an extensive colonic resection, subtotal or total colectomy, diagnosis of short bowel syndrome or a history of >3 small bowel resections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForalumabAlso: Human anti-CD3 monoclonal antibody (mAb)Foralumab will be administered per dose and schedule specified in the arm description. | Drug | Cohort 1: Foralumab Dose Level 1, Cohort 2: Foralumab Dose Level 2, Cohort 3: Foralumab Dose Level 3, Cohort 4: Foralumab Dose Level 4 |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 14
Adverse events categorized and graded via CTCAE
1 secondary outcome
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Day 5 and Day 12
Time frame: Baseline, Day 5 and Day 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Foralumab in people with Crohn's Disease, run by Tiziana Life Sciences LTD.
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 10 inclusion and 21 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 20 Oct 2022. 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. 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 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Day 1 up to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2022.