Ulcerative ColitisPhase 1NCT06080048
A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients With Ulcerative Colitis
A Phase 1 study testing SOR102 in people with Ulcerative Colitis, run by Sorriso Pharmaceuticals, Inc. at 2 sites in 2 countries.
Trial summary
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- SOR102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Oct 2023to 8 Nov 2024
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or females, of any ethnic origin.
- Established diagnosis of UC by standard criteria for >3 months.
- Disease evaluable by sigmoidoscopy.
- Mildly to severely active UC as determined by central reader in combination with other assessments of disease
Who cannot join
- Any diagnosis of IBD except for UC.
- History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
- Concurrent use of any biologic drug.
- Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
- Conditions
- Ulcerative Colitis
- Being tested
- SOR102, 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.
SOR102Drug
SOR102 capsules
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Part 3 SOR102 QD | Experimental | SOR102 once a day for 6 weeks SOR102 oral capsules Receives: Drug: SOR102 |
| Part 3 SOR102 BID | Experimental | SOR102 twice a day for 6 weeks SOR102 oral capsules Receives: Drug: SOR102 |
| Part 3 Placebo | Placebo comparator | Placebo for twice a day for 6 weeks Placebo oral capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events following oral dosing
After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group
Measured: Up to 6 weeks in Part 3 or at the time of study discontinuation
Secondary outcomes (3)
SOR102 concentrations following oral dosing
To determine the concentration of SOR102 in serum, urine and feces.
Measured: Up to 6 weeks in Part 3 or at the time of study discontinuation
Incidence of positive ADAs to SOR102
To assess the incidence of positive ADAs to SOR102.
Measured: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Incidence of positive neutralizing ADA
To assess the incidence of positive neutralizing ADA to SOR102 and its monomers in patients with positive ADA to SOR102.
Measured: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start24 Oct 2023
- Primary completion16 Oct 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorriso Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos C Sattler, MD, Study director, Sorriso Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080048
- Sponsor's protocol ID
- SOR102-101
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jairath V, Danese S, D'Haens GR, Feagan BG, Peyrin-Biroulet L, Sands BE, Gaemers I, Westfall M, Terry AQ, Roberts KJ, Barbat S, Wedel P, Benson JM, Sattler C. Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):34-45. doi: 10.1016/S2468-1253(25)00296-1. Epub 2025 Nov 13.
PubMed 41242336
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06080048
- Acronym / sponsor ID
- SOR102-101
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sorriso Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 12 Oct 2023 (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.
SOR102-101 is a Phase 1, 3-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of SOR102 (Part 1) and multiple oral doses (Part 2) of SOR102 in healthy adult participants, and to assess the safety, tolerability, PK, and biological activity of multiple oral doses of SOR102 in patients with mild to severe UC (Part 3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 3 SOR102 QD | Experimental | Drug: SOR102SOR102 once a day for 6 weeks SOR102 oral capsules |
| Part 3 SOR102 BID | Experimental | Drug: SOR102SOR102 twice a day for 6 weeks SOR102 oral capsules |
| Part 3 Placebo | Placebo comparator | Drug: PlaceboPlacebo for twice a day for 6 weeks Placebo oral capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or females, of any ethnic origin.
- Established diagnosis of UC by standard criteria for >3 months.
- Disease evaluable by sigmoidoscopy.
- Mildly to severely active UC as determined by central reader in combination with other assessments of disease
Key exclusion criteria (4 listed)
- Any diagnosis of IBD except for UC.
- History of fistula(e), strictures or surgery, known intestinal obstruction, or diagnosis of toxic megacolon.
- Concurrent use of any biologic drug.
- Prior primary efficacy failure or secondary loss of response to more than one biologic or new small molecule therapy (i.e., JAK inhibitors or S1P receptor modulators) indicated for the treatment of UC. This does not include prior discontinuation due to drug intolerance.
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 |
|---|---|---|
| SOR102SOR102 capsules | Drug | Part 3 SOR102 BID, Part 3 SOR102 QD |
| PlaceboMatching placebo capsules | Drug | Part 3 Placebo |
Primary outcome
Treatment Emergent Adverse Events following oral dosing
Time frame: Up to 6 weeks in Part 3 or at the time of study discontinuation
After multiple oral doses administered BID or QD, number of subjects with AEs in the SOR102 dose level cohorts compared with the oral placebo group
3 secondary outcomes
SOR102 concentrations following oral dosing
Time frame: Up to 6 weeks in Part 3 or at the time of study discontinuation
Incidence of positive ADAs to SOR102
Time frame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Incidence of positive neutralizing ADA
Time frame: Following 6 weeks of study treatment in Part 3 or at the time of study discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 41242336Jairath V, Danese S, D'Haens GR, Feagan BG, Peyrin-Biroulet L, Sands BE, Gaemers I, Westfall M, Terry AQ, Roberts KJ, Barbat S, Wedel P, Benson JM, Sattler C. Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial. Lancet Gastroenterol Hepatol. 2026 Jan;11(1):34-45. doi: 10.1016/S2468-1253(25)00296-1. Epub 2025 Nov 13.
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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.
Carlos C Sattler, MD study director
Sorriso Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOR102 in people with Ulcerative Colitis, run by Sorriso Pharmaceuticals, Inc. at 2 sites in 2 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Georgia, Ukraine. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment Emergent Adverse Events following oral dosing (time frame: Up to 6 weeks in Part 3 or at the time of study discontinuation). 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 NCT06080048, which also lists 1 linked publication.
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 29 Nov 2024.