Trial Outcomes & Findings for Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism (NCT NCT05823012)
NCT ID: NCT05823012
Last Updated: 2025-07-03
Results Overview
Geometric mean ratio of the weekly dose of XP-8121 to the daily dose of oral levothyroxine (aka dose conversion factor), where the XP-8121 dose corresponds to the administration immediately preceding collection of blood TSH used to determine normalization at the end of Maintenance Period. The dose conversion factor was assessed by comparing the natural log-transformed final XP-8121 dose in μg that maintained normalized TSH throughout the Maintenance Period to the natural log-transformed daily oral levothyroxine dose the participant was taking before the study, using a linear mixed effects model with treatment as the fixed effect and subject as the random effect. Geometric least square means (LSMs) were calculated by exponentiating the LSM from the ANOVA. The geometric mean ratio and the corresponding 90% CI was found by exponentiating the differences of log-transformed LSM and 90% confidence interval (CI) of the difference.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Day 29 of the Maintenance Period
Results posted on
2025-07-03
Participant Flow
Participants were recruited over an approximate 7.5 month period at medical research centers with experience in hypothyroidism.
A total of 140 potential participants were screened, 46 participants were enrolled, and 94 potential participants were screen failures. The most common reasons for screen failure were fT4 and TSH outside of the normal range as required by the eligibility criteria.
Participant milestones
| Measure |
XP-8121
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
|---|---|
|
Titration Period
STARTED
|
46
|
|
Titration Period
COMPLETED
|
42
|
|
Titration Period
NOT COMPLETED
|
4
|
|
Maintenance Period
STARTED
|
42
|
|
Maintenance Period
COMPLETED
|
39
|
|
Maintenance Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
XP-8121
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
|---|---|
|
Titration Period
Adverse Event
|
1
|
|
Titration Period
Inability to Achieve a tolerable replacement dosage
|
3
|
|
Maintenance Period
Adverse Event
|
1
|
|
Maintenance Period
Inability to achieve a tolerable replacement dosage
|
1
|
|
Maintenance Period
Inability to achieve an adequate replacement dosage
|
1
|
Baseline Characteristics
Study of XP-8121 For the Treatment of Adult Subjects With Hypothyroidism
Baseline characteristics by cohort
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Baseline Body Mass Index
|
29.50 kg/m^2
n=5 Participants
|
|
Primary Hypothyroidism History
|
46 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Brand
Synthroid
|
9 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Brand
Other Brand or Generic
|
37 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
50 micrograms
|
14 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
75 micrograms
|
12 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
88 micrograms
|
3 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
100 micrograms
|
8 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
112 micrograms
|
3 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
125 micrograms
|
3 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
150 micrograms
|
2 Participants
n=5 Participants
|
|
Prior Daily Oral Levothyroxine Dose
175 micrograms
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 29 of the Maintenance PeriodPopulation: The Completer Population used for this analysis is defined as all participants who completed the Maintenance Period and exhibited normalized TSH throughout the Maintenance Period while on a stable dose of XP-8121 for approximately 6 weeks. Participants with a reduced dose at any point during the Maintenance Period were not included in the Completer Population.
Geometric mean ratio of the weekly dose of XP-8121 to the daily dose of oral levothyroxine (aka dose conversion factor), where the XP-8121 dose corresponds to the administration immediately preceding collection of blood TSH used to determine normalization at the end of Maintenance Period. The dose conversion factor was assessed by comparing the natural log-transformed final XP-8121 dose in μg that maintained normalized TSH throughout the Maintenance Period to the natural log-transformed daily oral levothyroxine dose the participant was taking before the study, using a linear mixed effects model with treatment as the fixed effect and subject as the random effect. Geometric least square means (LSMs) were calculated by exponentiating the LSM from the ANOVA. The geometric mean ratio and the corresponding 90% CI was found by exponentiating the differences of log-transformed LSM and 90% confidence interval (CI) of the difference.
Outcome measures
| Measure |
XP-8121
n=23 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Dose Conversion Factor
|
4.24 Ratio
Interval 4.06 to 4.42
|
—
|
PRIMARY outcome
Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
The Modified Draize Scale assessment of erythema and edema was conducted 30 (+/-5) minutes after each dosing. The Modified Draize Scale is a 5-point scale: 0-none, 1-very slight, 2-slight, 3-moderate, 4-severe.
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 1 Dosing · 0 - None
|
43 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 1 Dosing · 1 - Very Slight
|
3 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 1 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 1 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 1 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 2 Dosing · 0 - None
|
41 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 2 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 2 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 2 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 2 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 3 Dosing · 0 - None
|
41 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 3 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 3 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 3 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 3 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 4 Dosing · 0 - None
|
37 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 4 Dosing · 1 - Very Slight
|
5 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 4 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 4 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 4 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 5 Dosing · 0 - None
|
38 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 5 Dosing · 1 - Very Slight
|
4 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 5 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 5 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 5 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 6 Dosing · 0 - None
|
38 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 6 Dosing · 1 - Very Slight
|
3 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 6 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 6 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 6 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 7 Dosing · 0 - None
|
12 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 7 Dosing · 1 - Very Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 7 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 7 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 7 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 8 Dosing · 0 - None
|
12 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 8 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 8 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 8 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Titration Period: Week 8 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 1 Dosing · 0 - None
|
40 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 1 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 1 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 1 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 1 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 8 Dosing · 0 - None
|
40 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 8 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 8 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 8 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 8 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 15 Dosing · 0 - None
|
39 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 15 Dosing · 1 - Very Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 15 Dosing · 2 - Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 15 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 15 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 22 Dosing · 0 - None
|
37 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 22 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 22 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 22 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Erythema
Maintenance Period: Day 22 Dosing · 4 - Severe
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 1 Dosing in Titration Period through Day 22 Dosing in Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
The Modified Draize Scale assessment of erythema and edema was conducted 30 (+/-5) minutes after each dosing. The Modified Draize Scale is a 5-point scale: 0-none, 1-very slight, 2-slight, 3-moderate, 4-severe.
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 1 Dosing · 0 - None
|
44 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 1 Dosing · 1 - Very Slight
|
2 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 1 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 1 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 1 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 2 Dosing · 0 - None
|
43 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 2 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 2 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 2 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 2 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 3 Dosing · 0 - None
|
43 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 3 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 3 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 3 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 3 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 4 Dosing · 0 - None
|
41 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 4 Dosing · 1 - Very Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 4 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 4 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 4 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 5 Dosing · 0 - None
|
42 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 5 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 5 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 5 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 5 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 6 Dosing · 0 - None
|
41 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 6 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 6 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 6 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 6 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 7 Dosing · 0 - None
|
11 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 7 Dosing · 1 - Very Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 7 Dosing · 2 - Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 7 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 7 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 8 Dosing · 0 - None
|
12 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 8 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 8 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 8 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Titration Period: Week 8 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 1 Dosing · 0 - None
|
42 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 1 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 1 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 1 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 1 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 8 Dosing · 0 - None
|
42 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 8 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 8 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 8 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 8 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 15 Dosing · 0 - None
|
40 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 15 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 15 Dosing · 2 - Slight
|
1 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 15 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 15 Dosing · 4 - Severe
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 22 Dosing · 0 - None
|
39 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 22 Dosing · 1 - Very Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 22 Dosing · 2 - Slight
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 22 Dosing · 3 - Moderate
|
0 Participants
|
—
|
|
Tolerability Assessment: Modified Draize Scale - Edema
Maintenance Period: Day 22 Dosing · 4 - Severe
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 1 dosing in the Titration Period through Day 22 dosing in the Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The number of participants decreases in association with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
Injection site discomfort was assessed by each participant at 10 (+/-2) minutes post-injection.
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 1 Dosing · Yes
|
14 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 1 Dosing · No
|
32 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 2 Dosing · Yes
|
9 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 2 Dosing · No
|
34 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 3 Dosing · Yes
|
12 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 3 Dosing · No
|
31 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 4 Dosing · Yes
|
10 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 4 Dosing · No
|
32 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 5 Dosing · Yes
|
12 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 5 Dosing · No
|
30 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 6 Dosing · Yes
|
9 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 6 Dosing · No
|
32 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 7 Dosing · Yes
|
6 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 7 Dosing · No
|
7 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 8 Dosing · Yes
|
2 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Titration Period: Week 8 Dosing · No
|
10 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 1 Dosing · Yes
|
13 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 1 Dosing · No
|
29 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 8 Dosing · Yes
|
12 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 8 Dosing · No
|
30 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 15 Dosing · Yes
|
8 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 15 Dosing · No
|
33 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 22 Dosing · Yes
|
6 Participants
|
—
|
|
Tolerability Assessments: Injection Site Discomfort Evaluation
Maintenance Period: Day 22 Dosing · No
|
33 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 29 of the Maintenance PeriodProportion of participants enrolled with normalized TSH throughout the Maintenance Period
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
n=42 Participants
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Proportion of Participants With Normalized TSH Throughout the Maintenance Period
|
27 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Day 29 of the Maintenance PeriodProportion of participants enrolled with normalized TSH at the end of the Maintenance Period.
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
n=42 Participants
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Proportion of Participants With Normalized TSH at End of Maintenance Period
|
31 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Up to Day 29 of the Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Baseline
|
103.68 nmol/L
Standard Deviation 27.278
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 2 Dosing
|
88.17 nmol/L
Standard Deviation 23.019
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 3 Dosing
|
89.68 nmol/L
Standard Deviation 23.019
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 4 Dosing
|
92.44 nmol/L
Standard Deviation 24.104
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 5 Dosing
|
94.26 nmol/L
Standard Deviation 22.059
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 6 Dosing
|
97.38 nmol/L
Standard Deviation 22.056
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 7 Dosing
|
90.29 nmol/L
Standard Deviation 18.867
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Titration Period: Week 8 Dosing
|
88.58 nmol/L
Standard Deviation 25.032
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Maintenance Period: Day 1 Dosing (Baseline)
|
103.45 nmol/L
Standard Deviation 24.970
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Maintenance Period: Day 8 Dosing
|
102.24 nmol/L
Standard Deviation 23.704
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Maintenance Period: Day 15 Dosing
|
103.35 nmol/L
Standard Deviation 23.508
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Maintenance Period: Day 22 Dosing
|
104.67 nmol/L
Standard Deviation 19.389
|
—
|
|
Thyroid Hormone Concentrations: Total Thyroxine
Maintenance Period: Day 29
|
101.97 nmol/L
Standard Deviation 24.532
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29 of the Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Baseline
|
14.60 pmol/L
Standard Deviation 2.713
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 2 Dosing
|
12.09 pmol/L
Standard Deviation 2.209
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 3 Dosing
|
11.69 pmol/L
Standard Deviation 2.494
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 4 Dosing
|
12.47 pmol/L
Standard Deviation 2.668
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 5 Dosing
|
12.84 pmol/L
Standard Deviation 2.417
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 6 Dosing
|
12.88 pmol/L
Standard Deviation 1.977
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 7 Dosing
|
12.32 pmol/L
Standard Deviation 1.814
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Titration Period: Week 8 Dosing
|
13.26 pmol/L
Standard Deviation 1.840
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Maintenance Period: Day 1 Dosing (Baseline)
|
14.50 pmol/L
Standard Deviation 2.411
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Maintenance Period: Day 8 Dosing
|
14.36 pmol/L
Standard Deviation 2.319
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Maintenance Period: Day 15 Dosing
|
14.24 pmol/L
Standard Deviation 2.147
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Maintenance Period: Day 22 Dosing
|
14.27 pmol/L
Standard Deviation 1.917
|
—
|
|
Thyroid Hormone Concentrations: Free Thyroxine (fT4)
Maintenance Period: Day 29
|
14.14 pmol/L
Standard Deviation 1.796
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29 of the Maintenance PeriodPopulation: The number of participants at each timepoint is dependent on the number of participants dosed at each timepoint. The overall number follows the decrease associated with study withdrawal, with the exception of the reduction in the number of participants in Titration Periods Week 7 and Week 8 due to the number of participants that transitioned to the Maintenance Period after dosing at Week 6.
Thyroid hormone concentrations (total thyroxine, free protein-unbound thyroxine (fT4), and TSH) following the first dose of XP-8121 during the Titration Period and Maintenance Periods
Outcome measures
| Measure |
XP-8121
n=46 Participants
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection).
|
Participants Who Entered the Maintenance Period
All participants who received XP-8121 (100 to 1500 μg subcutaneous injection), completed the Titration Period, and entered the Maintenance Period.
|
|---|---|---|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Baseline
|
1.958 mIU/L
Standard Deviation 1.0778
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 2 Dosing
|
3.942 mIU/L
Standard Deviation 2.8299
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 3 Dosing
|
6.534 mIU/L
Standard Deviation 8.2589
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 4 Dosing
|
6.162 mIU/L
Standard Deviation 8.8632
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 5 Dosing
|
6.397 mIU/L
Standard Deviation 9.8016
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 6 Dosing
|
5.506 mIU/L
Standard Deviation 7.1427
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 7 Dosing
|
8.326 mIU/L
Standard Deviation 8.5120
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Titration Period: Week 8 Dosing
|
5.752 mIU/L
Standard Deviation 5.3967
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Maintenance Period: Day 1 Dosing (Baseline)
|
2.967 mIU/L
Standard Deviation 2.1827
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Maintenance Period: Day 8 Dosing
|
2.920 mIU/L
Standard Deviation 2.7009
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Maintenance Period: Day 15 Dosing
|
2.739 mIU/L
Standard Deviation 2.8858
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Maintenance Period: Day 22 Dosing
|
2.494 mIU/L
Standard Deviation 2.0766
|
—
|
|
Thyroid Hormone Concentrations: Thyroid Stimulating Hormone (TSH)
Maintenance Period: Day 29
|
2.493 mIU/L
Standard Deviation 1.5087
|
—
|
Adverse Events
Titration Period
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Maintenance Period
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Overall
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Titration Period
n=46 participants at risk
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection) during the Titration Period.
|
Maintenance Period
n=42 participants at risk
All participants who received at least 1 dose of XP-8121 (100 to 1500 μg subcutaneous injection) during the Maintenance Period. Includes only includes those participants that completed the Titration Period and entered the Maintenance Period.
|
Overall
n=46 participants at risk
Includes all participants that received XP-8121 (100 to 1500 μg subcutaneous injection) in both Titration and Maintenance Treatment Periods.
|
|---|---|---|---|
|
General disorders
Fatigue
|
21.7%
10/46 • Number of events 12 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
0.00%
0/42 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
21.7%
10/46 • Number of events 12 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
General disorders
Injection site pain
|
6.5%
3/46 • Number of events 4 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.8%
2/42 • Number of events 2 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
10.9%
5/46 • Number of events 6 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
General disorders
Temperature intolerance
|
4.3%
2/46 • Number of events 3 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
0.00%
0/42 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.3%
2/46 • Number of events 3 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Infections and infestations
Urinary tract infection
|
6.5%
3/46 • Number of events 3 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
0.00%
0/42 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
6.5%
3/46 • Number of events 3 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Investigations
Weight increased
|
2.2%
1/46 • Number of events 1 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
2.4%
1/42 • Number of events 1 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.3%
2/46 • Number of events 2 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Nervous system disorders
Headache
|
8.7%
4/46 • Number of events 5 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
0.00%
0/42 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
8.7%
4/46 • Number of events 5 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46 • Number of events 1 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
2.4%
1/42 • Number of events 1 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.3%
2/46 • Number of events 2 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.2%
1/46 • Number of events 5 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
2.4%
1/42 • Number of events 1 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.3%
2/46 • Number of events 6 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.3%
2/46 • Number of events 2 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
0.00%
0/42 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
4.3%
2/46 • Number of events 2 • From Screening through the End of Maintenance Visit (Day 29) or up to 14 (+/-2 days) after last dose of XP-8121 for participants who withdrew prematurely
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The publication policy allows the Sponsor to submit a multi-center publication within 18-month period after the study is completed at all institutions. If it is not submitted within such 18-month period, an individual PI may furnish the Sponsor with a copy of any proposed publication or release at least 90 days in advance of the proposed submission or presentation. The Sponsor may review such proposed publication or release and may request a delay in publication of up to an additional 90 days.
- Publication restrictions are in place
Restriction type: OTHER