Trial · NCT05295732

The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis

NCT05295732, Phase 3, Completed, LEO Pharma; results first posted 2025-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis. Trials, record NCT05295732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05295732

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis
NCT number: NCT05295732
Status: Completed
Phases: Phase 3
Enrollment: 153 participants, actual
Lead sponsor: LEO Pharma
Conditions: Ichthyosis
Interventions: TMB-001, Matching Vehicle
First posted: 2022-03-25
Last updated: 2026-05-22
Other registries' IDs: eudract:2022-000459-35
Results first posted: 2025-11-17

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Investigator Global Assessment (IGA) Score	12 weeks	Comparison of proportions of subjects in percentages with ≥2-point changes from Baseline in Investigator Global Assessment (IGA)-scaling and fissuring scores in the Treatment Area at Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Secondary	Number of Subjects With IGA Scores	12 weeks	Comparison of proportion of subjects in percentages with IGA scores of clear or almost clear at Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Secondary	Change in IGA-scaling Severity Sub-score	12 weeks	Comparison of proportion of subjects in percentages who achieve IGA-scaling severity sub-score improvement ≥ 2-points from Baseline to Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Secondary	Change in Worst Itch-Quality of Life (QoL) Scores	12 weeks	Comparison of proportion of subjects in percentages with ≥4-point improvement from baseline in Worst Itch-QoL scores at Week 12 in subjects with baseline WI-NRS of ≥7 between TMB-001 0.05% and vehicle-treated subjects. Itch-Numeric Rating Scale (I-NRS) and Worst Itch-Numeric Rating Scale (WI-NRS) is an 0-10 scale where 0 is "no itching" and 10 is "worst itch imaginable".
Secondary	Change in Visual Index of Ichthyosis Severity (VIIS) Score	12 weeks	Comparison of proportion of subjects in percentages who achieve 50% reduction from Baseline in VIIS-scaling scores at Week 12 in all areas with Baseline VIIS score ≥3 between TMB-001 0.05% and vehicle-treated subjects. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Secondary	Change in VIIS Score	12 weeks	Comparison of proportion of subjects in percentages who achieve 25% reduction from Baseline in VIIS-scaling scores at Week 12 in all areas with Baseline VIIS score ≥3 between TMB-001 0.05% and vehicle-treated subjects. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Secondary	Change in IGA-fissuring Severity Sub-scores	12 weeks	Comparison of proportion of subjects in percentages achieving ≥2 point improvement in IGA-fissuring severity sub-scores from Baseline to Week 12 between TMB-001 0.05% and vehicle-treated subjects. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Secondary	Change in IGA Score	24 weeks	Comparison of proportions of subjects in percentages achieving ≥2-point improvement from Baseline in IGA scores at Week 24 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing. Investigator's Global Assessment Score is a 0-4 scale, where 0 is clear and 4 is severe.
Secondary	Change in VIIS Score	24 weeks	Comparison of proportion of subjects in percentages who achieve 50% reduction from Baseline in VIIS-scaling scores at Week 24 in all areas with Baseline VIIS score ≥3 between subjects randomized to TMB-001 0.05% BID and QD maintenance dosing. Visual Index for Ichthyosis Severity Score is a 0-4 scale where 0 is clear and 4 is severe.
Secondary	Change in Ichthyosis Quality of Life (IQoL)-32 Scores	12 weeks	Comparison of proportions of subjects in percentages with ≥11-point changes from Baseline in IQOL-32 scores at Week 12 between TMB-001 0.05% and vehicle-treated subjects. The IQoL-32 is a questionnaire containing 32, each scored from 0 to 4 ('not applicable', 'not at all', 'a little', 'a lot', 'tremendously') for a total score that varies between 0 and 128. A higher score, the higher impact on quality of life.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Investigator Global Assessment (IGA) Score	12 weeks	For the primary efficacy endpoint, missing Week 12 IGA scores were imputed by a multiple imputation approach and IGA responder status was derived from the imputed values. The analysis was then performed on each of the 50 imputed datasets. The final proportion of responders is the average proportion across all 50 imputed datasets hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Number of Subjects With IGA Scores	12 weeks	Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in IGA-scaling Severity Sub-score	12 weeks	Data is not available for 3 participants in the TMB-001 0.05% group and for 2 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in Worst Itch-Quality of Life (QoL) Scores	12 weeks	Data is not available for 59 participants in the TMB-001 0.05% group and for 29 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in Visual Index of Ichthyosis Severity (VIIS) Score	12 weeks	Data is not available for 4 participants in the TMB-001 0.05% group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in VIIS Score	12 weeks	Data is not available for 4 participants in the TMB-001 0.05% group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in IGA-fissuring Severity Sub-scores	12 weeks	Data is not available for 48 participants in the TMB-001 0.05% group and for 21 participants in the vehicle group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in IGA Score	24 weeks	Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in VIIS Score	24 weeks	Data reported for the re-randomized TMB-001 0.05% responders subjects in TMB-001 0.05% BID group. Missing values were imputed by a multiple imputation approach and the final proportion of responders is the average proportion across all imputed datasets, hence the proportion is not an exact fraction of the total number of subjects.	percentage of responders	NUMBER
SECONDARY	Change in Ichthyosis Quality of Life (IQoL)-32 Scores	12 weeks	Data is not available for 44 participants in the TMB-001 0.05% group and for 17 participants in the vehicle group.	percentage of responders	NUMBER

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group76

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Change in Investigator Global Assessment (IGA) Score	TMB-001 0.05%	41.4	percentage of responders
Change in Investigator Global Assessment (IGA) Score	Vehicle	44.9	percentage of responders
Number of Subjects With IGA Scores	TMB-001 0.05%	35.8	percentage of responders
Number of Subjects With IGA Scores	Vehicle	38.9	percentage of responders
Change in IGA-scaling Severity Sub-score	TMB-001 0.05%	40.4	percentage of responders
Change in IGA-scaling Severity Sub-score	Vehicle	36.4	percentage of responders
Change in Worst Itch-Quality of Life (QoL) Scores	TMB-001 0.05%	54.4	percentage of responders
Change in Worst Itch-Quality of Life (QoL) Scores	Vehicle	68.7	percentage of responders
Change in Visual Index of Ichthyosis Severity (VIIS) Score	TMB-001 0.05%	47.2	percentage of responders
Change in Visual Index of Ichthyosis Severity (VIIS) Score	Vehicle	42.7	percentage of responders

1 to 10 of 76Source ClinicalTrials.gov

See all 76 results by group

Participant flow35

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 3: Double-blind / MUsT: Treatment	STARTED	TMB-001 0.05%	79
Phase 3: Double-blind / MUsT: Treatment	STARTED	Vehicle	40
Phase 3: Double-blind / MUsT: Treatment	STARTED	TMB-001 0.05% QD	0
Phase 3: Double-blind / MUsT: Treatment	STARTED	TMB-001 0.05% BID	0
Phase 3: Double-blind / MUsT: Treatment	STARTED	Maximal Use	34
Phase 3: Double-blind / MUsT: Treatment	Dosed	TMB-001 0.05%	78
Phase 3: Double-blind / MUsT: Treatment	Dosed	Vehicle	38
Phase 3: Double-blind / MUsT: Treatment	Dosed	TMB-001 0.05% QD	0
Phase 3: Double-blind / MUsT: Treatment	Dosed	TMB-001 0.05% BID	0
Phase 3: Double-blind / MUsT: Treatment	Dosed	Maximal Use	34

1 to 10 of 35Source ClinicalTrials.gov

See all 35 participant flow

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Application site dermatitis	General disorders	Double-blinded Phase: TMB-001 0.05%	1	78	1
other	Application site dermatitis	General disorders	Double-blinded Phase: Vehicle	0	38	0
other	Application site dermatitis	General disorders	Open-label Phase: TMB-001 0.05% QD	1	28	1
other	Application site dermatitis	General disorders	Open-label Phase: TMB-001 0.05% BID	2	38	2
other	Application site dermatitis	General disorders	Maximal Use	1	34	1
other	Application site erosion	General disorders	Double-blinded Phase: TMB-001 0.05%	14	78	18
other	Application site erosion	General disorders	Double-blinded Phase: Vehicle	2	38	2
other	Application site erosion	General disorders	Open-label Phase: TMB-001 0.05% QD	0	28	0
other	Application site erosion	General disorders	Open-label Phase: TMB-001 0.05% BID	4	38	8
other	Application site erosion	General disorders	Maximal Use	7	34	7

1 to 10 of 80Source ClinicalTrials.gov

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Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Double-blinded Phase: TMB-001 0.05%	0	78
Total, all-cause mortality	Double-blinded Phase: Vehicle	0	38
Total, all-cause mortality	Open-label Phase: TMB-001 0.05% QD	0	28
Total, all-cause mortality	Open-label Phase: TMB-001 0.05% BID	0	38
Total, all-cause mortality	Maximal Use	0	34
Total, other adverse events	Double-blinded Phase: TMB-001 0.05%	47	78
Total, other adverse events	Double-blinded Phase: Vehicle	17	38
Total, other adverse events	Open-label Phase: TMB-001 0.05% QD	11	28
Total, other adverse events	Open-label Phase: TMB-001 0.05% BID	14	38
Total, other adverse events	Maximal Use	22	34

1 to 10 of 15Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41406959	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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